1.0 PURPOSE:
2.0 SCOPE:
3.0 DEFINITIONS:
4.0 RESPONSIBILITY:
4.1 QA personnel are responsible for control of analytical document.
4.2 Head – QA is responsible for the implementation / compliance of the procedure.
5.0 PROCEDURE:
5.1 After final review of all type of analytical documents by the QC reviewer, QC personnel shall hand over the same to QA department. After receiving the documents QA personnel shall fill and verify the check list.
5.2 QC department shall hand over all the analytical method validation and method transfer protocol and reports to quality assurance department after final approval.
5.3 The quality assurance department personnel make the master copy of same and issue the control copy to the quality control department.
5.4 If any document required for reference purpose the same document shall be given to Quality control department by stamping as reference copy.
5.5 All the documents related to quality control department shall be kept in QA documentation room after final review by the quality assurance personnel.
5.6 OOS, OOT reports shall hand over to QA personnel after its closer, where as all the laboratory incidence shall be handed over to QA personnel at the end of the calendar year.
5.7 All the validation report of microbiology department shall be hand over to QA personnel after final review.
5.8 All the analytical documents shall be filed with a unique identification number.
5.9 The details of each analytical file shall be updated in the respective log.
6.0 ABBREVIATIONS:
6.1 SOP : Standard Operating Procedure.
6.2 No. : Number.
6.3 QA : Quality Assurance.
6.4 COA : Certificate Of Analysis
6.5 OOS : Out of Specification.
6.6 QC : Quality control
6.7 OOT : Out of trend
7.0 REFERENCES:
8.0 LIST OF ANNEXURES:
Also read: SOP for cleaning validation in pharma.
Also read: SOP for Change control programme in pharma