cGMP/PROCESSES
PRODUCTION & PROCESS CONTROL
Written production and process control procedures shall be followed in manufacturing of drug product and any deviation from written procedures must be recorded and justified.
general requirements
- To assure not less than 100% of APIs label claim
- Dispensing of components already released by quality control department
- Each step of production performed by one person and verified by second person
- Claculation of yield at each appropriate phase of production
- Equipment identification
- Sampling and testing of inprocess materials
- Time limitations on each phase of production
- Reprocessing of batches to ensure that reprocessed batch conform to specifications
Phone
03334115785
Location
554, Sundar Industrial Estate Lahore
info@pmdconsultancy.com