GMP Audit Check List- Personnel and Premises

PERSONNEL

1. Is up-dated organization chart showing arrangement for quality assurance including production and quality control available?
2. is up dated technical staff list is available with following information - Name, qualification and years of relevant experience of responsible pharmacists, Chemist in Production, Quality Assurance & Quality Control?
3. Are production and Quality Assurance/ Quality control functions independent of each other?

4.      Are all unit areas adequately staffed?

5.      Is there proper supervision in every unit?

6.      Is hiring of an employee proceeded by a medical examination?

7.      Is this examination done periodically ?

8.      who is responsible for reporting/checking health of  employee?

9.      Is an employee whose states of health is doubtful immediately removed from the work site until she/he has recovered?

10.  Is there system of reporting back after illness?

11.  Is medical assistance available during the normal working hours?

12.  Are there suitable washing, changing and rest areas?

13.  Is the clothing suitable for the activity undertaken? Briefly describe the clothing.

14.  Are there clear instructions on how protective clothing should be used and when it should be changed?

15.  Is in-house or external laundry used?

16.  Have all personnel received GMP training? A. Induction B. Continuous

17.  Is training manual/syllabus of GMP available and enclosed?

18.  Do all personnel receive up-dated GMP training? How often?………

19.  Is record of training details (induction/continuous) provided to each staff in-house available and enclosed?

20.  Is efficacy of training assessed by questionnaire?

PREMISES

1. Are there any sources of pollution (industrial or other) in the neighborhood of the building?
2. Is well-labeled plant lay-out of suitable size, design and construction for each areas of production and control available/enclosed?
3. Is the plant so constructed and maintained to protect against. a) Weather, flood, ground seepage? b Access and harboring of vermin, rodents, birds, insects and other animals?
4. Is there an adequate working space for a) Orderly and logical placement of equipment and materials? b) Efficient flow of work? c) Effective communication?
5. Are buildings and facilities properly constructed to facilitate smooth operation and adequate cleaning?
6. Are room arrangements adequate, to prevent mix-up and/or cross-contamination of products?
7. Are lighting and ventilation adequately designed and installed?
8. Is schematic drawings/data on design criteria (specification of the air supply, temperature, humidity, pressure differential and air change rate, re-circulation percentage), filter design/efficiency, limits for changing filters, validation, re-validation frequency provided?
9. Are toilets: a) not open directly to production areas? b) well ventilated?
10. Are sewage, trash and other effluent disposal adequate?
11. Are floors, walls and ceilings constructed of materials which will facilitate easy cleaning and if necessary Dis infections?
12. Are products of other highly toxic/hazardous products, cephalosporins, steroids/hermones, cytotoxics well segregated?
13. Is schematic description of water system including sanitation provided? ( Indicate city supply, capacity, vessel materials/pipework, filters specification, store/circulating temperature, specification of water produced, sampling points, frequency testing, procedure and frequency of sanitation)
14. Are there preventative maintenance and servicing programme/procedure/reporting available? ( Indicate the frequency of services /checks, details of services/repairs/modification, critical maintenance that could affect product quality, access/use of maintenance records)