CHAPTER 5 - PRODUCTION

PIC/S GMP
GENERAL

• No limit of yield for bulk / Finish goods to ensure there are no discrepancies outside
acceptable limits (only implement with reconciliation in BPR)
GENERAL

• No label or identify on major equipment of what is being processed. => e.g.?

PREVENTION OF CROSS-CONTAMINATION IN
PRODUCTION

• No risk assessment of these possible contamination.

PREVENTION OF CROSS-CONTAMINATION IN
PRODUCTION

• No quality risk management assess about all above factors.

PREVENTION OF CROSS-CONTAMINATION IN
PRODUCTION

• No measurement of prevention cross-contamination and checking for its effectiveness.

• Currently has monthly cleaning monitoring program, re-validation cleaning validation only for
direct product contact part
STARTING MATERIALS

• No supply chain traceability.

• No audit at manufacturers and
distributor of API.
STARTING MATERIALS

• Form FWH001-01 not mention to check tamper evident at

container
STARTING MATERIALS

• No weight checking of material by manu operator.

PROCESSING OPERATIONS: INTERMEDIATE AND
BULK PRODUCTS

• Haven’t had limit for the expected yield yet

PACKAGING OPERATIONS

• Still have complaint/RB detective about fading coding.

 PACKAGING OPERATIONS

• Current record form

do not have
destruction record
and separately
between off-line
coding step and line
packing step.
PACKAGING OPERATIONS