Batch Manufacturing Records and GMP for Primary Operations (APIs)
For process operators employed in the manufacture of active pharmaceutical ingredients.
Pharmaceutical Regulatory Guidelines stipulate that one of the basic requirements of GMP is that records are made, manually or electronically, which demonstrate that all steps required by the defined procedure and instructions, were in fact taken.
The aim of these training DVDs is to focus on the importance of batch manufacturing records and how they should be completed so as to ensure that a safe and effective product has been produced to the quality that was expected every time.
- the vital link between batch manufacturing records and GMP.
- what they are, where they originate, and why we need them.
- the principles of documentation.
- the procedure for completing batch records.
- the basic rules for filling in hand-written documents.
- the significance of signatures and countersignatures.
- the importance of recording process deviations.
- the interrelation between batch manufacturing records and traceability.
On completion the participant will understand:
- the unique properties and component parts of a batch manufacturing record.
- how batch manufacturing records impact on GMP.
- the meaning of a deviation report and to be able to give examples.
- what is meant by correct and incorrect hand written entries.
- the end uses on completion of a batch manufacturing record.
- the importance of a properly completed batch manufacturing record and the production of a safe and effective product.