Study Set Content:
Based on the stability of the raw materials the re assay dates are: 24 months
active ingredients, excipients
are primary concerns for the pharmaceutical industry.
Compliance, traceability, consistency, and reliability of measurement data
The control system(s) in place need to verify the product quality through
- measuring, counting, inspection and testing of the manufacturing process
are being observed which encompass the six major systems in an industrial pharmacy
Process control systems
- Process control systems are being observed which encompass the six major systems in an industrial pharmacy which includes:
- Quality
- Production
- Laboratory
- Materials
- Facilities &Equipment
- Packaging & Labeling
Includes measures and activities to control the manufacture of in-process materials and drug products including
Production system
Includes measures and activities to control the manufacture of in-process materials and drug products including:
- batch compounding
- dosage form production
- in-process sampling and testing and
- process validation
- establishing, following, and documenting
- performance of approved manufacturing procedures
- assure that the drug products have the identity, strength, quality, and purity they purport or represent to possess.
Written procedures;
- The batch shall be formulated with the intent to provide not less than 100 percent of the labeled or established amount of active ingredient
Charge-in components
Any deviation from the written procedures shall be recorded and justified
Written procedures; deviations
- Requires determination of actual yields and % theoretical yield
) Calculation of yield
Components for drug product manufacturing shall be weighed, measured, or subdivided as appropriate.
Charge-in components
Requires proper identification (ID) of all equipment at all times during production
Equipment identification
- Requires establishing and following written procedures
Sampling and testing of in-process materials and drug products
Requires establishing valid in-process specifications for such characteristics
Sampling and testing of in-process materials and drug products
Requires testing of in-process materials for identity, strength, quality, and purity as appropriate
Sampling and testing of in-process materials and drug products
Requires identification and recording of a major equipment by a distinctive ID number or code in the batch production record
Equipment identification
- Requires establishing time limits for the completion of each phase of production when appropriate.
Time limitations on production
shall not be performed without the review and approval of the quality control unit
reprocessing
- A receiving tally report should be prepared; information indicated in a RTR is as follows: Pre-printed data
- Information to be supplied by:
A. Warehouse
B. Quality Control
Summary Process of Material Control
