GMP/DOCUMENTATION
RECORDS
Good documentation practice plays pivotal role in Pharmaceutical manufacturing. In cGMP not recorded means not performed.
EQUIPMENT CLEANING & USAGE RECORDS
TESTING RECORDS
RAW AND PACKAGING MATERIALS RECORDS
COMPLAINT HANDELING RECORDS
BATCH MANUFACTURING RECORDS
DEVIATIONS AND CAPA RECORDS
GENERAL REQUIREMENTS
Batch processing and testing records must be maintained at least one year after the expiry of drug product.
Record should also be maintained for drug components, primary and secondary packaging mateirals, inprocess and finished drug products.
Annual quality review
Annual review of complaints, recalls, returned drug products
IMPORTANT RECORDS TO BE MAINTAINED
- Equipment cleaning and usage log books
- Components, Drug Products, Containers, Closures and Labeling Records
- Mater Formulas
- Batch Manufacturing and Packaging Records
- Quality Control Testing Records
- Distribution Records
- Complaints and recalls records
Phone
03334115785
Location
554, Sundar Industrial Estate Lahore
info@pmdconsultancy.com