PERSONNEL
- Is up-dated organization chart showing an arrangement for quality assurance including production and quality control available?
- is updated technical staff list is available with the following information - Name, qualification and years of relevant experience of responsible pharmacists, Chemist in Production, Quality Assurance & Quality Control?
- Are production and Quality Assurance/ Quality control functions independent of each other?
- Are all unit areas adequately staffed?
- Is there proper supervision in every unit?
- Is hiring of an employee proceeded by a medical examination?
- Is this examination done periodically?
- who is responsible for reporting/checking health of employee?
- Is an employee whose states of health is doubtful immediately removed from the work site until she/he has recovered?
- Is there a system of reporting back after illness?
- Is medical assistance available during the normal working hours?
- Are there suitable washing, changing and rest areas?
- Is the clothing suitable for the activity undertaken? Briefly describe the clothing.
- Are there clear instructions on how protective clothing should be used and when it should be changed?
- Is in-house or external laundry used?
- Have all personnel received GMP training? A. Induction B. Continuous
- Is training manual/syllabus of GMP available and enclosed?
- Do all personnel receive up-dated GMP training? How often?………
- Is record of training details (induction/continuous) provided to each staff in-house available and enclosed?
- Is efficacy of training assessed by questionnaire?
PREMISES
- Are there any sources of pollution (industrial or other) in the neighborhood of the building?
- Is well-labeled plant layout of suitable size, design, and construction for each area of production and control available/enclosed?
- 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?
- Is there an adequate working space for a) Orderly and logical placement of equipment and materials? b) The efficient flow of work? c) Effective communication?
- Are buildings and facilities properly constructed to facilitate smooth operation and adequate cleaning?
- Are room arrangements adequate, to prevent mix-up and/or cross-contamination of products?
- Are lighting and ventilation adequately designed and installed?
- 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?
- Are toilets: a) not open directly to production areas? b) well ventilated?
- Are sewage, trash and another effluent disposal adequate?
- Are floors, walls and ceilings constructed of materials which will facilitate easy cleaning and if necessary Disinfections?
- Are products of other highly toxic/hazardous products, cephalosporins, steroids/hormones, cytotoxics well segregated?
- 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)
- 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)
Also see: GMP Audit Check List- Storage of Starting Material
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nice to have such informations at single site.
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