Professional Documents
Culture Documents
PharDose Chapter 3
Current Good Manufacturing Practices and Current Good
Compounding Practices
Common Terms used by cGMP for finshed pharmaceuticals
1. API Active Pharmaceutical Ingredient is any
component intended to furnish phamocological
activity or a direct effect on the diagnosis, cure ,
mitigation of a disease,
2. BATCH a specifc qty of a drug of uniform quality
produced accdg to a single manufactiuring order
3. BATCHWISE CONTROL
4. CERTIFICATION
5. COMPLIANCE
6. COMPONENT
7. DRUG PRODUCT
8. LOT
9. LOT NUMBER
10. MASTER RECORD
11. QUALITY ASSURANCE
12. QUALITY AUDIT
13. QUALITY CONTROL
14. QUALITY CONTROL UNIT
15. QUARANTINE
16. RERESENTATIVE SAMPLE
17. REPROCESSING
18. STRENGTH
19. STRENGTH
20. VERIFIED
21. VALIDATION
22. PROCESS VALIDATION
23. VALIDATION CONTROL
The organization and personnel section require that a
quality control unit have the authority and responsibility
for all functions like accepting or rejecting product
components, specifications, finished products, packaging
and labeling
All personnel have the training, education and/or
experience
Building and Facilities structure , spaces, design must be
such to enable thorough cleaning, inspection, safe and
effective use of equipment. Factors such as water quality,
security on materials, separate areas for quarantine,
rejected materials, for quality approval, for weighing, etc
EQUIPMENT - Each piece must be of appropriate design ,
size and location with written standard operating
procedures
CONTROL OF COMPONENTS. CONTAINERS AND CLOSURES
1. Received components must be logged with
purchase order number, date, bill of lading,
name of supplier and qty
2. Assign a control number for identification and is to
be followed throughout the production for tracing
PRODUCTION AND PROCESS CONTROLS
Written procedures on charge-in of all components, use of
in-process controls, sample testing and process and
equipment validation. The operator records date and time
of each key operations. Products are labeled as to
contents and status. In-process samples are taken to
ensure that the machinery is producing output within preestablished control limits
PACKAGING AND LABELING CONTROLS
1. Labeling of drugs on strength, dosage form, qty
mut be stored with proper identification
2.
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