IADSA GMP Self Assessment Tool on Good Manufacturing Practice for Supplements

This checklist has been developed to accompany the IADSA global Guide to Good Manufacturing Practice for Supplements.*

Each series of questions is specifically related to a chapter of the IADSA Guide. By completing the questionnaire, companies will be able to assess their GMP status and identify possible gaps in their operations, through a ‘No’ response to a question.

Estimated time to complete: 30 - 45 min

* http://www.iadsa.org/publications/1308262592_Global_Guide_to_Good_Manufact.pdf

1 COMPANY INFORMATION

1.1 Type of business *This question is required.

Manufacturing / Packaging	Packaging only	Contract manufacturer / Packer	Marketing
Manufacturing / Packaging	Packaging only	Contract manufacturer / Packer	Marketing

1.2 No. of full-time *This question is required.

1.3 No. of part-time / seasonal *This question is required.

1.4 Does your company manufacture and / or pack supplements *This question is required.

Manufacturing	Storage	Laboratories	Overall
Manufacturing	Storage	Laboratories	Overall

1.5 Does your company manufacture and / or pack supplements *This question is required.

On site	At another site within group	Contract out manufacturing	Contract out packing
On site	At another site within group	Contract out manufacturing	Contract out packing

2 QUALITY MANAGEMENT

2.1 Is your company registered / registering for an accredited quality system, e.g. ISO? *This question is required.

Yes	No
Yes	No

If Yes, which?

*This question is required.

2.2 Does the company have personnel specifically responsible for quality (e.g. Quality Control / Quality Assurance Manager)? *This question is required.

Yes	No
Yes	No

If Yes, are the authority and responsibilities of these personnel clearly defined?

*This question is required.

Yes	No
Yes	No

2.3 Do these personnel have the authority to make independent decisions on product quality? *This question is required.

Yes	No
Yes	No

2.4 Is there documented evidence for all lots (batches) of product that demonstrates the following

all steps during manufacture are being carried out as per the defined procedures
quantity and quality produced are as expected
finished batches are enclosed in the proper container and bear the correct label
finished products are stored, distributed, and recommendations given for subsequent handling

*This question is required.

Yes	No
Yes	No

2.5 Are reference samples retained of:

– Starting materials? *This question is required.

Yes	No
Yes	No

– Finished products in the final pack? *This question is required.

Yes	No
Yes	No

2.6 Are there procedures in place to define the process of pulling above samples? *This question is required.

Yes	No
Yes	No

2.7 Are there procedures in place to ensure the traceability of all raw material, intermediate and finished product? *This question is required.

Yes	No
Yes	No

2.8 Do the traceability records allow for rapid identification of:

– The suppliers of the raw materials *This question is required.

Yes	No
Yes	No

– The complete manufacturing history of a lot of finished product *This question is required.

Yes	No
Yes	No

– The businesses to which finished products have been supplied? *This question is required.

Yes	No
Yes	No

2.9 Is the information on traceability in a form that can be made available to the authorities on demand? *This question is required.

Yes	No
Yes	No

2.10 Is there a Supplier Quality Assurance procedure in place, laying down the criteria for selection, approval, review and ongoing approval, to ensure that the supplied products and services meet the expected requirements? *This question is required.

Yes	No
Yes	No

2.11 Are the Quality Assurance procedures of suppliers of raw and packaging materials monitored? *This question is required.

Yes	No
Yes	No

2.12 Is there a program in place to determine environmental quality *This question is required.

Yes	No
Yes	No

2.13 Is there a system in place allowing rapid feedback to the purchasing department if concerns are raised on the quality of purchased materials? *This question is required.

Yes	No
Yes	No

2.14 Is there a system in place allowing rapid feedback to the manufacturing department regarding modifications or corrective actions to be taken, if required? *This question is required.

Yes	No
Yes	No

2.15 Are summaries of quality performance data and advice (where relevant) regularly given to manufacturing personnel? *This question is required.

Yes	No
Yes	No

2.16 Is there a system in place to ensure changes to relevant legislation are promptly noted and applied where applicable? *This question is required.

Yes	No
Yes	No

2.17 Are results of inspection and testing of material reviewed against established specifications? *This question is required.

Yes	No
Yes	No

2.18 Does product assessment include the review of relevant manufacturing and packaging documentation? *This question is required.

Yes	No
Yes	No

2.19 Is product dispositioned by Quality? *This question is required.

Yes	No
Yes	No

3 PREMISES AND EQUIPMENT

Premises

3.1 Is there a Maintenance Plan that ensures the condition of buildings (both internal and external)? *This question is required.

Yes	No
Yes	No

3.2 Equipment is regularly reviewed and action taken when necessary? *This question is required.

Yes	No
Yes	No

3.3 Are the floor, wall, ceilings, windows, and doors easily cleanable? *This question is required.

Yes	No
Yes	No

3.4 Are the manufacturing areas separate and distinct from other functional areas such maintenance and laboratories? *This question is required.

Yes	No
Yes	No

Ventilation and Lighting

3.5 Are manufacturing and packaging areas ventilated with a constant supply of appropriately filtered air to ensure contaminants are not introduced into products? *This question is required.

Yes	No
Yes	No

3.6 Where required, is there a system in place to monitor temperature, and humidity? *This question is required.

Yes	No
Yes	No

3.7 Are there shatterproof covers on lights in the following areas: − raw material storage area?

− Raw material storage area? *This question is required.

Yes	No
Yes	No

− Manufacturing areas? *This question is required.

Yes	No
Yes	No

− Finished products storage area? *This question is required.

Yes	No
Yes	No

3.8 Is there a formal glass, ceramic, or hard plastic breakage control procedure? *This question is required.

Yes	No
Yes	No

Floors, walls, and ceilings

3.9 Are the floors in the manufacturing areas made of an impervious and non-absorbent material? *This question is required.

Yes	No
Yes	No

3.10 Are the floors free from cracks and joints in areas where product is exposed? *This question is required.

Yes	No
Yes	No

3.11 Do drains have trapped gullies and proper ventilation? *This question is required.

Yes	No
Yes	No

3.12 Are all open drainage channels shallow and easy to clean? *This question is required.

Yes	No
Yes	No

3.13 Are walls intact, free of faults, and finished with a smooth, impervious, and easily cleaned material? *This question is required.

Yes	No
Yes	No

3.14 Are windows made of toughened glass or plastic? *This question is required.

Yes	No
Yes	No

3.15 Are there screens on windows that open? *This question is required.

Yes	No
Yes	No

3.16 Do window ledges slope away from the glass at an angle to prevent items being placed on them? *This question is required.

Yes	No
Yes	No

3.17 Do doors have smooth, non-absorbent, easy to clean and disinfect surfaces? *This question is required.

Yes	No
Yes	No

3.18 Does the ceiling construction in manufacturing areas prevent the accumulation of dirt/growth of mold/shedding of particles? *This question is required.

Yes	No
Yes	No

Cleaning and waste

3.19 Is there a Site Hygiene Plan or Master Sanitation Schedule? *This question is required.

Yes	No
Yes	No

If Yes, is the plan regularly reviewed?

*This question is required.

Yes	No
Yes	No

3.20 Is there a process in place to control the disposal of printed packaging materials or raw materials and rejected products? *This question is required.

Yes	No
Yes	No

3.21 Is production waste collected in clearly identifiable receptacles for removal to specific collection points outside the buildings? *This question is required.

Yes	No
Yes	No

3.22 Is production waste removed from the manufacturing areas throughout the day? *This question is required.

Yes	No
Yes	No

3.23 How often is waste removed from the site? *This question is required.

Yes	No
Yes	No

3.24 Are cleaning products approved for their intended use? *This question is required.

Yes	No
Yes	No

3.25 Are cleaning products stored in a location that is separate from the processing areas? *This question is required.

Yes	No
Yes	No

Receiving and dispatch areas

3.26 Do the receiving and dispatch areas provide protection from the weather for materials or product in transit? *This question is required.

Yes	No
Yes	No

3.27 Where appropriate, is there a defined deboxing/debagging area for those materials which arrive in external packaging? *This question is required.

Yes	No
Yes	No

Personnel hygiene facilities

3.28 Are the following provided:

- Changing rooms or facilities segregated from production area? *This question is required.

Yes	No
Yes	No

- Toilet and hand washing facilities segregated from manufacturing areas? *This question is required.

Yes	No
Yes	No

- Separate accommodation for clothing and footwear not being worn during working hours? *This question is required.

Yes	No
Yes	No

- First Aid facilities and an accident book? *This question is required.

Yes	No
Yes	No

- A rest and refreshment room segregated from production area? *This question is required.

Yes	No
Yes	No

Pest control

3.29 Is there a Pest Control program in place? *This question is required.

Yes	No
Yes	No

3.30 Is pest control contracted out? *This question is required.

Yes	No
Yes	No

If No, are personnel trained to oversee pest control and are there appropriate procedures in place for in-house pest management?

*This question is required.

Yes	No
Yes	No

3.31 What steps are taken to protect against the entrance and harboring of vermin, birds, pests and pets in all buildings on site? *This question is required.

Yes	No
Yes	No

Equipment

3.32 Are all surfaces and materials in contact with raw materials and finished product:

- Inert to the raw materials / product? *This question is required.

Yes	No
Yes	No

- Microbiologically cleanable, smooth and non-porous? *This question is required.

Yes	No
Yes	No

- Visible for inspection (or equipment is easily dismantled for inspection)? *This question is required.

Yes	No
Yes	No

- Easily dismantled and readily accessible for cleaning? *This question is required.

Yes	No
Yes	No

3.33 Do you have cleaning procedures for all equipment and areas? *This question is required.

Yes	No
Yes	No

3.34 Do you have documented results to show that your cleaning procedure is sufficient for manual and clean-in-place techniqu *This question is required.

Yes	No
Yes	No

3.35 Is all equipment cleaned and serviced immediately after use? *This question is required.

Yes	No
Yes	No

3.36 Are fumes from power driven equipment, heaters etc. ventilated away from the manufacturing areas? *This question is required.

Yes	No
Yes	No

3.37 Are there maintenance procedures in place for all equipment *This question is required.

Yes	No
Yes	No

3.38 Is all equipment regularly serviced and calibrated? *This question is required.

Yes	No
Yes	No

If Yes, are appropriate records maintained?

*This question is required.

Yes	No
Yes	No

Are these regularly checked to ensure calibration is up to date and equipment is working accurately?

*This question is required.

Yes	No
Yes	No

3.39 Are there procedures in place outlining the action to be taken in the event of a recognized malfunction of the inspection and testing equipment? *This question is required.

Yes	No
Yes	No

Water

3.40 Is the water supply monitored and controlled? *This question is required.

Yes	No
Yes	No

3.41 Is potable water the minimum standard used for all manufacturing purposes? *This question is required.

Yes	No
Yes	No

3.42 Is the water that is used for all manufacturing purposes periodically analyzed? *This question is required.

Yes	No
Yes	No

4 PERSONNEL AND TRAINING

Training

4.1 Is training given to all new employees? *This question is required.

Yes	No
Yes	No

If Yes, does this training include personal hygiene?

*This question is required.

Yes	No
Yes	No

4.2 Is additional appropriate regular training offered to personnel? *This question is required.

Yes	No
Yes	No

4.3 For full time personnel, is their training subjected to formal review and assessment? *This question is required.

Yes	No
Yes	No

4.5 Are individual training records kept and maintained? *This question is required.

Yes	No
Yes	No

4.6 Do office, maintenance and cleaning staff and any contractors who enter the production or storage areas receive hygiene instructions? *This question is required.

Yes	No
Yes	No

4.7 Are employees trained on principles of product safety, including the potential for microbiological, chemical, and foreign body hazards? *This question is required.

Yes	No
Yes	No

Hygiene

4.8 Is appropriate protective clothing, including safety footwear and suitable overclothing provided to employees? *This question is required.

Yes	No
Yes	No

4.9 Is there a requirement for protective outerwear to be removed when leaving the manufacturing areas? *This question is required.

Yes	No
Yes	No

4.10 Are pre-employment medical checks carried out? *This question is required.

Yes	No
Yes	No

4.11 Are all visitors made aware of the Company’s hygiene policy? *This question is required.

Yes	No
Yes	No

4.12 Is there a reporting procedure for staff suffering from, or who are in close contact with people suffering from, specific medical conditions? *This question is required.

Yes	No
Yes	No

4.13 Is there a personal medication procedure in place? *This question is required.

Yes	No
Yes	No

4.15 Are there clear written policies in place:

- On the wearing of wristwatches and jewelry in the manufacturing areas? *This question is required.

Yes	No
Yes	No

- On items of clothing or jewelry that may be allowed in the manufacturing areas for medical, ethnic or religious reasons? *This question is required.

Yes	No
Yes	No

- On the carrying of loose items (pens, mobile phones etc.) in the same areas? *This question is required.

Yes	No
Yes	No

- On the removal of protective clothing before break periods and on leaving the production area? *This question is required.

Yes	No
Yes	No

4.16. Are procedures in place for hand washing? *This question is required.

Yes	No
Yes	No

- Do the procedures address the maintenance of fingernails clean, short, and unvarnished?

*This question is required.

Yes	No
Yes	No

4.17 Is antibacterial cream, foam or gel available for applying after hand washing for personnel working in areas of high microbiological sensitivity? *This question is required.

Yes	No
Yes	No

4.18 Is there a procedure in place to control glove issue? *This question is required.

Yes	No
Yes	No

5 PRODUCT AND PROCESS DEVELOPMENT

5.1 Are checks carried out on all new products to establish whether the ingredients and formulation are suitable, safe and legal for all intended markets? *This question is required.

Yes	No
Yes	No

5.2 Are the same checks as above carried out when any significant change is proposed e.g. change of raw material or equipment? *This question is required.

Yes	No
Yes	No

5.3 Are potential allergen sources identified during the development process? *This question is required.

Yes	No
Yes	No

5.4 Has stability been checked (either through actual stability tests or the use of previously confirmed data) and the shelf life correctly determined for:

- All products? *This question is required.

Yes	No
Yes	No

- Risk products? *This question is required.

Yes	No
Yes	No

5.5 Is shelf life testing a requirement of the product development program? *This question is required.

Yes	No
Yes	No

5.6 Are proposed labels checked to ensure they conform to all relevant labelling legislation? *This question is required.

Yes	No
Yes	No

5.7 Are all proposed claims checked to ensure they comply with current legislation? *This question is required.

Yes	No
Yes	No

5.8 For all new or revised products, is the appropriateness and legality of the packaging checked to ensure compliance? *This question is required.

Yes	No
Yes	No

5.9 Are all new and revised products checked to ensure that the planned methods and procedures are suitable and that consistent quality products can be produced? *This question is required.

Yes	No
Yes	No

6. MANUFACTURE

6.1 Does each product have:

- A defined and authorized Master Formula? *This question is required.

Yes	No
Yes	No

- Defined and authorized Master Manufacturing Instructions? *This question is required.

Yes	No
Yes	No

- Related Standard Operating Procedures? *This question is required.

Yes	No
Yes	No

6.2 Are all instructions and operating procedures clear and unambiguous and written in the official working language of the manufacturing facility? *This question is required.

Yes	No
Yes	No

6.3 Have appropriate trials been undertaken for each product to confirm that the formulation, methods and procedures specified in the Master Manufacturing Instructions:

- Are suitable for factory production? *This question is required.

Yes	No
Yes	No

- Are capable of consistently yielding products within the Finished Product Specification? *This question is required.

Yes	No
Yes	No

6.4 Are periodic checks undertaken to ensure the Master Manufacturing Instructions are being followed and that they are still applicable and relevant? *This question is required.

Yes	No
Yes	No

6.5 Have the following been developed and brought to the attention of all relevant personnel:

- Written operating procedures for each piece of equipment / instrument? *This question is required.

Yes	No
Yes	No

- Written instructions detailing the action to be taken in the event of stoppages, breakdowns or other unexpected events? *This question is required.

Yes	No
Yes	No

- Formal procedures setting out the action to be taken in the event of foreign body contamination at any stage during the manufacturing process? *This question is required.

Yes	No
Yes	No

Production

6.6 Have procedures been established for ensuring that the work area and equipment are clean and free from any starting material, packaging material, products, product-residues or documents before production begins? *This question is required.

Yes	No
Yes	No

6.7 During production, are all materials, bulk containers and major items of equipment labeled to indicate the stage of manufacture and status, where applicable? *This question is required.

Yes	No
Yes	No

6.8 Is the final yield, and any significant intermediate yield, of each production lot recorded and checked against the expected yield within defined limits? *This question is required.

Yes	No
Yes	No

Raw materials

6.9 Are detailed specifications established for all raw materials? *This question is required.

Yes	No
Yes	No

6.10 Are internal lot (batch) numbers allocated to all raw materials? *This question is required.

Yes	No
Yes	No

6.11 Are the contents of all containers identified? *This question is required.

Yes	No
Yes	No

6.12 Are raw materials entering the premises quarantined until they appropriately checked and a decision made on their status i.e. whether approved or rejected? *This question is required.

Yes	No
Yes	No

6.13 Are all raw material lots (batches) tested and laboratory records maintained? *This question is required.

Yes	No
Yes	No

If No, specify what portion are tested *This question is required.

6.14 Are Certificates of Analysis (CoA) for raw materials checked to confirm compliance with the specifications? *This question is required.

Yes	No
Yes	No

If Yes, are periodic checks undertaken to verify the quality of the supplier’s CoAs?

*This question is required.

Yes	No
Yes	No

6.15 Are the temperature and humidity for storing raw materials controlled and recorded? *This question is required.

Yes	No
Yes	No

If Yes, what are the tolerances?

*This question is required.

6.16 Are there procedures in place for issuing raw materials from storage? *This question is required.

Yes	No
Yes	No

6.17 Is correct stock rotation followed when issuing raw materials from storage? *This question is required.

Yes	No
Yes	No

6.18 Is there a procedure in place for the reconciliation of the quantities of raw materials issued against the quantity of product manufactured? *This question is required.

Yes	No
Yes	No

6.19 When lot quantities are dispensed manually into containers in advance, is this process done in a segregated area? *This question is required.

Yes	No
Yes	No

6.20 Are all weighings checked by a second operator or by use of a validated computerized weighing control system? *This question is required.

Yes	No
Yes	No

Packaging and labelling materials

6.21 Are packaging materials certified for food contact use (i.e. in conformance with current legislation on materials and articles in contact with food)? *This question is required.

Yes	No
Yes	No

6.22 Is there a procedure in place to ensure that changes in product formulation are reflected in the label copy? *This question is required.

Yes	No
Yes	No

6.23 Are internal reference codes allocated to each delivery or lot/batch of packaging material? *This question is required.

Yes	No
Yes	No

6.24 Is packaging material entering the premises quarantined until it is appropriately checked and a decision made on its status i.e. whether approved or rejected? *This question is required.

Yes	No
Yes	No

6.25 Are stocks of packaging materials in storage inspected regularly to check their condition? *This question is required.

Yes	No
Yes	No

6.26 Is stock rotation followed when issuing packaging materials from storage? *This question is required.

Yes	No
Yes	No

6.27 Are all packaging materials inspected immediately before use? *This question is required.

Yes	No
Yes	No

6.27 Are procedures in place for:

- The issue of packaging materials from storage?

*This question is required.

Yes	No
Yes	No

- The return of part-used lots of packaging to storage?

*This question is required.

Yes	No
Yes	No

- The reconciliation of all printed packaging component stock from quantity issued, quantity used, wastage and that returned to store? *This question is required.

Yes	No
Yes	No

- The re-sealing of part-used boxes of packaging, to prevent foreign contamination?

*This question is required.

Yes	No
Yes	No

- The removal and destruction of superseded packaging or labels?

*This question is required.

Yes	No
Yes	No

Processing and packaging

6.29 Are multiple packaging lines (where present) segregated to avoid the risk of cross-contamination? *This question is required.

Yes	No
Yes	No

6.30 Are the following checks always carried out before the start of any process:

- The name and appropriate reference to the product being processed is clearly displayed on each production line?

*This question is required.

Yes	No
Yes	No

- The production area is clean and free from any items not relevant to the process to be undertaken? *This question is required.

Yes	No
Yes	No

-The correct materials and documents have been issued?

*This question is required.

Yes	No
Yes	No

- The correct machine settings have been made?

*This question is required.

Yes	No
Yes	No

- All plant and equipment is clean and ready for use?

*This question is required.

Yes	No
Yes	No

-Are in-process conditions monitored (e.g. by sensory, instrumental and / or laboratory testing, correct packaging and date-marking)?

*This question is required.

Yes	No
Yes	No

6.31 Are in-process conditions monitored (e.g. by sensory, instrumental and / or laboratory testing, correct packaging and date-marking)? *This question is required.

Yes	No
Yes	No

6.32 Are samples analyzed:

- During production?

*This question is required.

Yes	No
Yes	No

- After production? *This question is required.

Yes	No
Yes	No

If Yes, are these samples tested:

In-house	Contract Laboratory
In-house	Contract Laboratory

- Are the samples during production tested according to pre-set specifications?

*This question is required.

Yes	No
Yes	No

6.33 Are intermediate products and packed finished products quarantined until checked and approved by Quality Control? *This question is required.

Yes	No
Yes	No

6.34 Are there procedures in place for the management of non-conforming products? *This question is required.

Yes	No
Yes	No

Intermediate and finished products

6.35 Are products quarantined until it is appropriately checked and a decision made on its status i.e. whether approved or rejected? *This question is required.

Yes	No
Yes	No

6.36 Does Quality Control release all products for sale once the appropriate checks are completed and acceptable? *This question is required.

Yes	No
Yes	No

6.37 Are all results that fail to meet the specification investigated? *This question is required.

Yes	No
Yes	No

Disposal of waste and effluent

6.38 Is the disposal of printed packaging materials, raw materials and reject product appropriately controlled? *This question is required.

Yes	No
Yes	No

6.39 Is a reconciliation carried out on quantities of materials or product used and/or produced against those being disposed of? *This question is required.

Yes	No
Yes	No

6.40 Are all waste materials and effluent disposed of by a route appropriate to the class of material? *This question is required.

Yes	No
Yes	No

7 RECOVERY OR RE-WORKING OF MATERIALS

7.1 Are there procedures in place to control recovered, reworked, or reprocessed material? *This question is required.

Yes	No
Yes	No

7.2 Is the recovery, re-working or re-processing of materials or products clearly documented and these records kept for a previously decided period? *This question is required.

Yes	No
Yes	No

7.3 Is recovered, reworked, or reprocessed material quarantined until checked by Quality Control and a disposition decision is made? *This question is required.

Yes	No
Yes	No

7.4 Is there a system in place to ensure that when there is doubt regarding the quality of materials or product, they should not be recovered, reworked, or re-processed but are destroyed? *This question is required.

Yes	No
Yes	No

7.5 Are authorized and validated methods used for re-processing? *This question is required.

Yes	No
Yes	No

7.6 Are finished products that have been returned from the market assessed and released by Quality Control before consideration is given for re-sale? *This question is required.

Yes	No
Yes	No

8 STORAGE

Access to storage areas

8.1 Is access to material and product storage areas restricted to those working in these areas and to other authorized persons? *This question is required.

Yes	No
Yes	No

8.2 Is there a suitable curtain at all entrances and exits of the storage area? *This question is required.

Yes	No
Yes	No

8.3 Is there a suitable curtain at all entrances and exits of the storage area? *This question is required.

Yes	No
Yes	No

Temperature and lighting

8.4 Is temperature mapping and recording carried out in the storage area(s)? *This question is required.

Yes	No
Yes	No

Product storage

8.5 Is lighting set as high as possible above product and have shatterproof protective covers? *This question is required.

Yes	No
Yes	No

8.6 Is a stock rotation system followed? *This question is required.

Yes	No
Yes	No

8.7 Are all aisles in the storage area(s) kept clear? *This question is required.

Yes	No
Yes	No

8.8 Is pest control in place in the storage area(s)? *This question is required.

Yes	No
Yes	No

8.9 Are pallets regularly checked for structural integrity? *This question is required.

Yes	No
Yes	No

8.10 Are packed products stored in conditions necessary for safe storage, appropriate to their specifications? *This question is required.

Yes	No
Yes	No

8.11 Are stored materials and product clearly identifiable, even when stacked? *This question is required.

Yes	No
Yes	No

8.12 Is there a specific quarantine area for material deliveries/product batches awaiting results of testing? *This question is required.

Yes	No
Yes	No

Cleaning of storage areas

8.13 Is there a specific holding area for damaged goods, awaiting Quality Control inspection? *This question is required.

Yes	No
Yes	No

Damaged goods

8.14 Are the storage facilities periodically inspected:

- For cleanliness? *This question is required.

Yes	No
Yes	No

- For pest infestation? *This question is required.

Yes	No
Yes	No

- To identify materials and product exceeding its shelf life? *This question is required.

Yes	No
Yes	No

8.15 Are such inspections documented and any corrective actions noted? *This question is required.

Yes	No
Yes	No

8.16 Are there procedures in place for cleaning of the storage premises and equipment? *This question is required.

Yes	No
Yes	No

9 TRANSPORT AND DISTRIBUTION

9.1 Are vehicle / container interiors inspected:

9.2 Are contaminated and damaged containers kept apart from those that are clean and in good condition? *This question is required.

Yes	No
Yes	No

- before loading materials / products? *This question is required.

Yes	No
Yes	No

- on unloading materials / products? *This question is required.

Yes	No
Yes	No

9.3 Are security measures in place that:

- Help deter tampering with goods in storage and distribution? *This question is required.

Yes	No
Yes	No

- Show whether any tampering has occurred? *This question is required.

Yes	No
Yes	No

9.4 Is there a written procedure to deal with damages occurring to goods during storage and distribution? *This question is required.

Yes	No
Yes	No

9.5 Are audits carried out on contracted-out transport facilities and procedures, where relevant? *This question is required.

Yes	No
Yes	No

9.6 Are the relevant personnel informed when care is needed to reduce large temperature fluctuations during transport and delivery? *This question is required.

Yes	No
Yes	No

10 DOCUMENTATION

10.1 Is there a written procedure covering the complete documentation system? *This question is required.

Yes	No
Yes	No

10.2 If Yes, does this include procedures for the:

- Maintaining the history of each lot of product? *This question is required.

Yes	No
Yes	No

- Issue of documents? *This question is required.

Yes	No
Yes	No

- Authorization of documents? *This question is required.

Yes	No
Yes	No

- Distribution of documents? *This question is required.

Yes	No
Yes	No

- Periodic review of documents? *This question is required.

Yes	No
Yes	No

- Revision of documents? *This question is required.

Yes	No
Yes	No

10.3 For electronic documentation, are there safeguards in place to ensure that:

- Data is entered correctly? *This question is required.

Yes	No
Yes	No

- Sufficient back-ups are made and retained? *This question is required.

Yes	No
Yes	No

- Unauthorized access is prevented? *This question is required.

Yes	No
Yes	No

10.4 Are relevant personnel given appropriate training on how to complete the documents? *This question is required.

Yes	No
Yes	No

- If Yes, is this training regularly reviewed?

*This question is required.

Yes	No
Yes	No

10.5 Are there safeguards in place to restrict the entering of data to authorized persons only? *This question is required.

Yes	No
Yes	No

10.6 Are any amendments to documentation clearly corrected and authorized? *This question is required.

Yes	No
Yes	No

10.7 Are superseded documents removed from active use and a copy retained, clearly marked as superseded? *This question is required.

Yes	No
Yes	No

10.8 Has a manual been prepared that describes the overall Quality Assurance system, the procedures employed and the documents used? *This question is required.

Yes	No
Yes	No

- If Yes, is this manual accessible to all relevant personnel?

*This question is required.

Yes	No
Yes	No

10.9 Are there procedures in place outlining the action to be taken in the event of system failure or breakdown? *This question is required.

Yes	No
Yes	No

10.10 Do you periodically review and revise your documentation system? *This question is required.

Yes	No
Yes	No

10.11 Are documents in place that describe product manufacturing and requirements (i.e. manufacturing formula, process instructions, packaging instructions, specifications, cleaning, testing, and equipment operation)? *This question is required.

Yes	No
Yes	No

10.12 In general, for how long are records retained? *This question is required.

10.13 Has it been confirmed that this complies with any legal requirements? *This question is required.

Yes	No
Yes	No

10.14 Are lot (batch) records retained for the shelf life of the product, plus one year? *This question is required.

Yes	No
Yes	No

10.15 Is personnel data retained in accordance with national laws on such data? *This question is required.

Yes	No
Yes	No

10.16 Is a Controlled Records List utilized? *This question is required.

Yes	No
Yes	No

10.17 Are there safeguards in place to protect all documentation (both electronic and paper copy) in the event of a fire? *This question is required.

Yes	No
Yes	No

11 COMPLAINTS PROCEDURE, PRODUCT RECALL AND EMERGENCY PROCEDURE

Complaints

11.1 Are there procedures in place for handling product related complaints? *This question is required.

Yes	No
Yes	No

11.2 Are personnel appropriately trained to ensure that all complaints are recognized, communicated and recorded? *This question is required.

Yes	No
Yes	No

11.3 Is the Quality Control Manager kept fully informed and closely consulted on all complaints? *This question is required.

Yes	No
Yes	No

11.4 Is there a procedure in place for handling complaints specifically related to adverse events? *This question is required.

Yes	No
Yes	No

If Yes, is there a designated person who is responsible for implementing and monitoring this procedure?

*This question is required.

Yes	No
Yes	No

11.5 Is complaint analysis carried out at periodic intervals? *This question is required.

Yes	No
Yes	No

11.6 Are summaries of complaints and / or trends sent to key senior personnel? *This question is required.

Yes	No
Yes	No

Product withdrawal and recall

11.7 Are there procedures in place for:

- Product withdrawal? *This question is required.

Yes	No
Yes	No

- Product recall? *This question is required.

Yes	No
Yes	No

11.8 Is there a nominated, responsible person and nominated deputies to co-ordinate recall activities? *This question is required.

Yes	No
Yes	No

11.9 Has a crisis management team been established? *This question is required.

Yes	No
Yes	No

11.10 Has the withdrawal/recall system been tested? *This question is required.

Yes	No
Yes	No

11.11 Are there procedures in place regarding the proper treatment of withdrawn or recalled material or product? *This question is required.

Yes	No
Yes	No

Emergency procedure

11.12 Are there procedures in place for responding to emergencies? *This question is required.

Yes	No
Yes	No

12 SELF-INSPECTION

12.1 Is there a prearranged program for self-inspections to monitor the implementation and compliance with GMP principles and to propose necessary corrective measures? *This question is required.

Yes	No
Yes	No

If yes, are they conducted at least once a year?

Yes	No
Yes	No

12.2 Are records made of all observations, corrective measures, and the subsequent action taken? *This question is required.

Yes	No
Yes	No

12.2 Are the self-inspections periodically reviewed by senior management? *This question is required.

Yes	No
Yes	No

13 SUB-CONTRACTING OPERATIONS

13.1 Is your company a Contract Giver? *This question is required.

Yes. If yes please go to question 13.3	No
Yes. If yes please go to question 13.3	No

13.2 Is your company a Contract Acceptor? *This question is required.

Yes. If yes please go to question 13.4	No
Yes. If yes please go to question 13.4	No

13.3 Contract Giver:

a) Is there a program for auditing the key suppliers i.e. those who supply ‘risk’ materials? *This question is required.

Yes	No
Yes	No

b) Are all suppliers assessed by means of:

- A site audit?

*This question is required.

Yes	No
Yes	No

- A self-assessment form?

*This question is required.

Yes	No
Yes	No

c) Are detailed product specifications agreed with every supplier?

*This question is required.

Yes	No
Yes	No

d) Are any special quality control / GMP requirements agreed with every supplier?

*This question is required.

Yes	No
Yes	No

e) Is there a Technical Agreement in place with every supplier?

*This question is required.

Yes	No
Yes	No

13.4 Contract Acceptor:

a) Are detailed product specifications agreed with every customer?

*This question is required.

Yes	No
Yes	No

b) Are detailed product specifications agreed with every customer?

*This question is required.

Yes	No
Yes	No

c) Is there a Technical Agreement in place with every customer

*This question is required.

Yes	No
Yes	No

14 LABORATORY TESTING

14.1 Is there an in-house company laboratory?

*This question is required.

Yes	No . If No, please go to question 14.5
Yes	No . If No, please go to question 14.5

- If Yes, is the laboratory accredited?

*This question is required.

Yes	No
Yes	No

14.2 Is all laboratory equipment and instrumentation regularly serviced and calibrated? *This question is required.

Yes	No
Yes	No

If Yes, are appropriate records maintained? *This question is required.

Yes	No
Yes	No

14.3 Are there written procedures for:

- each piece of equipment / instrument? *This question is required.

Yes	No
Yes	No

- reagent and standard preparation? *This question is required.

Yes	No
Yes	No

- sampling? *This question is required.

Yes	No
Yes	No

14.4 Are samples analyzed according to written procedures, using internationally accepted test methods or other methods that have been scientifically validated? *This question is required.

Yes	No
Yes	No

14.5 Does the laboratory use analytical methods that include a control step to verify the instrument is functioning accurately, when necessary? *This question is required.

Yes	No
Yes	No

14.6 Is there adequate storage space for storage of samples at the appropriate temperature? *This question is required.

Yes	No
Yes	No

14.7 Does your company use a contract laboratory? *This question is required.

Yes	No
Yes	No

If Yes, is the laboratory accredited? *This question is required.

Yes	No
Yes	No

14.8 Is the performance of the laboratory monitored and audited? *This question is required.

Yes	No
Yes	No