Friday, April 3, 2009

pharmaceutical cgmp

Proposals for GMP Certification

Areas on which work to be done for GMP certification
1. General provisions
2. Organization and personnel
3. Buildings and facilities
4. Equipment
5. Control of components, containers and closures
6. Production process controls
7. Packaging and labeling controls
8. Holding and distribution
9. Laboratory controls
10. Records and reports
11. Return and salvaged drug products
12. Self inspections

A General Provisions & Organization and Personnel
1. Name of Company
2. Owners Name & Address / Telephone no’s, Fax no’s and E-mail Address
3. Head Office (Administration Block) (Address / Telephone no’s, Fax no’s and E-mail Address)
4. Factory (Plant) (Address / Telephone no’s, Fax no’s and E-mail Address)
5. No of years in business
6. How company is controlled
7. Organization chart.
8. Operational Chart (if different from organization chart define how the company is controlled including in detail all functions that contribute to acceptance or rejection decisions excluding financial matters).
9. Field of business
10. Traveling Map from Head office to Plant.
11. Transport availability to Plant for workers and staff.
12. Company Conveyance to staff and workers.
13. Listing of leaves and other benefit on the board should be present.
14. No. of Department in Administration Block
15. Total no of employees
16. Collaboration with any other company
17. Membership in trade associations
18. Each department should be listed separately, and list should describe name of person, designation, qualification, date of appointment, experience, date of resignation. The pattern is described below.
Department: Quality Control, Production, Accounts etc.
Sr. No
Name of Person
Date of Appointment
Date of resignation

Technical Staff:
Sr. No
Name of Person
Date of Appointment
Date of resignation

i) List of Key personals with Telephone No. & addresses to whom may be contacted during emergency.
ii) The GMP requirement for every Employee should have the skill of writing, reading, and understanding skill and numericacy, for higher jobs, higher skills, higher qualifications are required.
v) Staff Training ( In order for quality control to function properly, key executives must be appropriately educated, trained, and experienced. They should be approachable and sensitized by training or experience to quality control problems.) similar case is with production staff.

The manufacturer should have and adequate no of personals with the necessary qualification and practical experience. The responsibility put on them should not be so extensive so as to put any risk to quality.
Key Personals:
i) Head of Production
ii) Head of Quality Control (both should be full time employer)
iii) The head of production department and quality control department must have sufficient experience and a degree in science and pharmacy.
Purchase department
iv) The purchaser should have the agreements with different suppliers, and have list of approved suppliers, vendors their telephone no’s, their capabilities, storage conditions, material packing sizes, list of materials and the time in which they can supply, facility of transport etc.
v) The purchaser should have the complete list of materials which can be locally purchased and imported.
vi) The purchaser should have the complete SOP & Specificaitons of importing materials.
vii) The purchaser should have a degree of pharmacy with 1 to 2 years practical experience of production.
viii) The duties of responsible persons should be specified (as J. D’s) and have full authority (which are already present). The qualification of other staff members other than production and Quality Control should be according to Company requirement

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