A Good Manufacturing Practice GMP Questionnaire for Excipients is a tool used to assess and qualify excipient suppliers to ensure compliance with regulatory standards and quality requirements.

Part I: To be Completed by Supplier

A) Contact Details
Name:
Address:
Postal Code, City:
Country:
Telephone / fax / E-mail:
Contact Person:
Is your company the subsidiary of another company or corporation?					Yes		No
If yes, please state name of parent company:
Number of local employees:
What services do you offer? (enclose a description, if applicable)
		Is your company certified according to MP (if yes, please enclose certificate)				Yes		No

Part II: To be Completed by Manufacturer Only

I confirm the correctness of the following information.
We / I agree that Pharmaceuticals Limited may share the following information with its associated companies;
a) where the associated company possesses MA licence(s) in which this excipient manufacturing site is named or
b) where the company is named as a finished product manufacturer on the relevant MA licences and uses excipient from this excipient manufacturing site:

Contact Data
Name:
Address / Post Office Box:
Postal Code, City:
Country:
Telephone / Telefax:
E-mail:
Contact Person:
Is your company the subsidiary of another company or corporation?				Yes	No
If yes, please state name of parent company:
Number of Sites:

Please complete the following questions in respect of each manufacturing site
Site Address GMP Questionnaire for Excipients

Address / Post Office Box:
Postal Code, City:
Country:
Telephone / Telefax:
Contact E-mail:

1) Number of Local Employees	Total
	Production
	Quality Control
	Quality Assurance
	Sales
2) Approx. area of your site in m2 (incl. warehouse):
3) How many shifts do your employees work?
4) Amount of your turnover per year percentage pharmaceutical products:
5) List products manufactured on site?
6) Do you produce or handle highly potent, toxic or sensitising materials (e.g. phenols, or azo dyes)?						Yes	No
7) Do you manufacture the same excipient at more than one site and if so, is it possible to determine at which site production took place?						Yes	No
8) Is your company GMP certified (if yes, please enclose certificate)						Yes	No
9) Do you supply your products with certificates of analysis for each batch?						Yes	No

Sr. No.	GMP Questionnaire for Excipients (Quality Assurance System)	Yes	No
1	Is the quality unit responsible for maintaining the Quality Assurance system independently from production?
2	Are your standard operating procedures and similar documents for Quality Assurance reviewed continuously and are outdated versions prevented from being used?
3	Do your employees have access to standard operating procedures at all times?
4	Do you have a programme for regularly carrying out internal audits and are these being documented?
5	Are records (specifications, data sheets, etc.) kept for all starting materials used?
6	Are all starting materials received checked as to whether they meet specifications (inspection of goods received, certificate of testing)?
7	Are all starting material suppliers periodically evaluated by you?
8	Does your company audit suppliers of quality critical materials?
9	Do you guarantee to inform your customer immediately of any changes regarding manufacturing and control processes, suppliers, etc.?
10	Is a change control procedure established including differentiation between major and minor changes?
11	Is a label reconciliation system in place, which prevents the misuse of labels?
12	Have adequate measures been taken to prevent mix-up?
13	Intermixing and cross-contamination over the entire course of production and in storage?
14	Will you make your quality manual available to your customers?

Sr. No.	GMP Questionnaire for Excipients (Personnel)	Yes	No
1	Have individual responsibilities been clearly defined in writing so that neither gaps nor overlaps will occur (adequately organized)?
2	Are your employees offered adequate training and are training records kept?

Sr. No.	GMP Questionnaire for Excipients (Rooms / Buildings)	Yes	No
1	Is a site master file (detailed description of your production buildings) available?
2	Are there written instructions / programmes on how to clean and disinfect your manufacturing area?
3	Do you have a pest control system in place?
4	Is storage temperature and humidity controlled with adequate conditions for the final product?

Sr. No.	GMP Questionnaire for Excipients (Hygiene)	Yes	No
1	Is there a hygiene programme which includes specified measures for all relevant areas (storage, flow of material, production and dispatch)?
2	Have precautionary measures been taken (also applies to your sub-suppliers) to ensure that no known carrier of infectious disease or employee with open wounds on uncovered parts of the body comes into direct contact with the products at any step of the manufacturing process?

Sr. No.	GMP Questionnaire for Excipients (Documentation)	Yes	No
1	Are written instructions available with regard to manufacturing processes, in-process-control, storage and quality control?
2	Are manufacturing and quality control processes documented and controlled?
3	Are written specifications available for products and key intermediates?
4	Are documents available to trace back starting materials of products (e.g. batch records, labelling)?
5	Are all available manufacturing documents signed and dated properly?
6	Is change documents signed and released by the responsible person?
7	All BPR and BMR records kept on file for at least 5 years or until the expiry date of the product plus 1 year, whichever is longer?

Sr. No.	GMP Questionnaire for Excipients (Manufacturing)	Yes	No
1	Is a documented maintenance (incl. calibration) program for the equipment in place?
2	Is a record or logbook in place for documentation of equipment maintenance, cleaning, repairs and calibration?
3	Is the equipment used for the production of different products thoroughly cleaned and checked for cleanliness prior to the manufacture of another product?
4	Are cleaning methods validated?
5	Are there manuals for use, cleaning and maintenance of equipment and machines?
6	Is the equipment labelled appropriately as to cleaning and operation status?
7	Have adequate measures been taken to prevent cross-contamination prior to each production step (e.g. control of line clearance)?
8	Is log book kept for equipment (Local maintain, calibration and service provider)?
9	Are finished product sample take for retention? If so, how long are they kept? _____________ Years
10	Is there a written programme to monitor microbiological parameters for? • Raw Materials? • Water? • Finished Products? • Air and surfaces of the packaging rooms?
11	Have critical manufacturing steps and any major changes in Processes?

Sr. No.	GMP Questionnaire for Excipients (Quality Control)	Yes	No
1	Do you have your own laboratories for quality control?
2	Are there certain tests which are carried out by contract laboratories for you?
3	Is the quality control department equipped with adequate instruments, rooms and personnel to properly execute its duties?
4	Are test methods validated?
5	Are internal inspections properly documented after being carried out?
6	Is an out-of-specification procedure (OOS) in place?
7	Are certificates of analysis prepared by quality control and signed by an authorised person in quality control?
8	Do your customers receive certificates of analysis upon request?
9	Have adequate measures been taken to keep products quarantined under defined conditions until final release?
10	Is a log book kept for instruments (documentation of maintenance, calibration)?
11	Are laboratory reagents dated upon receipt and when opened?
12	Are the reagents prepared in your laboratories? a) Marked with the name of the person preparing them? b) Dated when prepared and first used?
13	Are reference materials adequately stored and tested in intervals and documented?
14	Is a risk evaluation procedure in place for TSE / BSE?
15	Are returned goods investigated and the reasons for failure determined?

Sr. No.	GMP Questionnaire for Excipients (Goods Received, Storage, Dispatch & Transportation)	Yes	No
1	Is each delivery inspected for intact packaging and closure of the containers?
2	Is the storage area equipped with? • Temperature Control • Humidity Control
3	Are there procedures for the control of vermin (pest control)?
4	Are measures taken to prevent mixed pallets consisting of various products / batches for dispatch?
5	Are provisions made for shipping agents to handle the goods with appropriate care?

Sr. No.	GMP Questionnaire for Excipients (Complaints & Deficiencies)	Yes	No
1	Is a procedure in place for complaint handling?
2	Is a procedure in place for corrective action and preventive action (CAPA)?
3	Is rework/reprocessing done?
4	If yes: Is this performed according to standard procedures?
5	Is there a recall procedure in place?

Risk Assessment of Excipients

No.	Score                           Low		Score                           Medium		Score                           High
1		Ongoing and accelerated stability data available		Only accelerated stability data available		No stability data
2		Manufactured by synthetic route		Manufactured from plant origin		Manufactured from animal origin or unknown
3		Nontoxic & non flammable		Harmful, irritant & /or flammable		Toxic, flammable & explosive hazard
4		Potential of impurity from raw materials used in manufacturer of excipients		Potential of impurity from the by – products produced during manufacturing process		Potential of impurity from the degradation product produced during  manufacturing process
5		Obtained directly from the manufacturer		Supplied by a third party		Packed down by a third party
6		Quality management system implemented		Quality management system partially implemented		Quality management system not available
7		Potential of impurity from residual solvent		Potential of impurity from the catalysts used in manufacturing process		Potential of impurity from cross contamination
8		Evidence of cross contamination control		Cross contamination not fully controlled		Lack of cross contamination control
9		In date TSE / BSE certificate		Out date TSE? BSE certificate		No TSE / BSE certificate
10		Passes Pacific microbial test		Passes manufacturer microbial test		No microbiological test
11		Temper evident packaging by manufacturer		Temper evident packaging by supplier		No temper evident packaging
12		Transported by mfg. using data logger		Transported by supplier using data logger		No temperature monitoring
13		Low % content of RM in final product(0.1 – 1%)		Moderate % content of RM in final product (>1% to 10%)		Moderate % content of RM in final product (< 10%)
14		No known quality defect		Source known quality defect		Globally known quality defect
15		Pharmacopeia grade RM		Food grade  or/ non-Pharmacopeia grade RM		No grade reagent
16		Pacific tested for potential impurity		Manufacturer test for potential impurity		No test is dome for potential impurity
17		Oral route of administration		Ophthalmic route of administration		Parental route of administration
18		Excipients used as diluent		Excipients used as lubricant		Excipients used as disintegrates / binders
19		Excipients has no impact on quality attributes of products		Excipients has indirect impact on quality attributes of products		Excipients has direct impact on quality attributes of products
20		Company has complete quality system in place		Company has partial quality system in place		Company has no quality system in place
21		Company has sufficient competent and appropriately qualified staff		Company has insufficient  competent and appropriately qualified staff		Company lacks competent and appropriately qualified staff
22		Defined job description for managerial and supervisory staff responsible for manufacturing and quality activities		Defined job description for managerialstaff only responsible for manufacturing and quality activities. No job written job description of supervisor available		No defined job description for managerial and supervisory staff responsible for manufacturing and quality activities
23		Proper training programmes for all staff involved in manufacturing and quality activities		Improper training programmes for all staff involved in manufacturing and quality activities		No training programmes for all staff involved in manufacturing and quality activities
24		Proper training programmes related to health, hygiene and clothing as identified as necessary to the intended operations		Improper training programmes related to health, hygiene and clothing as identified as necessary to the intended operations		No training programmes related to health, hygiene and clothing as identified as necessary to the intended operations
25		Written procedure along with annual maintenance schedule available		Written procedure available but lack of annual maintenance schedule		No written procedure as well as annual maintenance schedule
26		Complete system for coding and identify staring material, intermediates and excipients to allow full traceability		Lack of proper system for coding and identify staring material, intermediates and excipients to allow full traceability		No system for coding and identify staring material, intermediates and excipients to allow full traceability
27		Qualification of vendors as per current EU GMP guidelines		Qualification of vendors as per local GMP guidelines		No system of vendor qualification
28		Independent QC with adequate staff and equipment		Independent QC with lack of adequate staff and equipment		No independent QC
29		Retention of all records for incoming material and excipients and retention of samples of excipients for the period required		Retention of all records for incoming material and excipients, but samples of excipients are not retained		No record of incoming material and no sample are retained
30		System to ensure to any activity contracted outside after auditing the services provider followed by written contract		No auditing of services provider, only written contract is available		No auditing no written contract with service provider
31		Effective system for complaints is  available and written procedure for recall of material having quality issues		Effective system for complaints is   available, but lack of written procedure  for recall of material having quality issues		No written procedure is available for complaints and recall
32		Written procedure for change control, deviation management available		Written procedure for change control, deviation management not clearly defined		No written procedure for change control &  deviation
33		Self-inspection program with quarterlyaudits of different departments is available		Self-inspection program is not well  defined for each department		No self-inspection program is available in company