The purpose of this SOP is to lay down a procedure for preparation, Approval, Issuance and Control of Analytical Testing Protocol.
This SOP is applicable for preparation, Approval, Issuance and Control of Analytical Testing Protocol in Quality Control Department at manufacturing facility of Pharmaceutical Industry.
PROCEDURE:
The Analytical Testing Protocol shall be prepared by Officer QC Or designated employee based on specification and standard testing procedure.
The Analytical Testing protocol shall be divided in to three parts .i.e. Chemical analysis, Instrumental analysis & Microbial analysis as required.
The prepared protocol shall be reviewed by quality control In charge for technical adequacy.
Final protocol shall be approved by Head-QA.
QA shall issue controlled copy to QC. This copy shall be used as master copy for QC.
The Quality control in charge or his designee shall issue the protocol to the individual chemist based on available sample for analysis with signature in first page and his initial on subsequent pages.
Issue shall be moved and testing shall be started.
All attachments as Balance printouts, chromatogram, spectra etc., shall be fix with protocol after duly signed.
QC In charge / QC Head OR authorized designee shall check the protocol and sign in the designated place.
Any deviation shall be documented.
TRAINING:
As per SOP ON Employee Training
DISTRIBUTION:
As per SOP ON SOP
ANNEXURE:
Nil
REFERENCES(S):
Nil