The pharmaceutical industry is highly dependent on quality control laboratory for their product quality enhancement. The analysis is a continuous happening process that demands a high level of supervision and periodic validation. To maintain the functional importance of analysis, regular supervision is very necessary. Therefore, SOP for supervision of analysis is followed in each laboratory. Here, you will find a complete SOP for supervision of analysis in a detailed manner.
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SOP for supervision of Analysis
1. Objective: To lay down a procedure for Supervision of Analysis.
2. Scope: The procedure of this SOP shall be applicable to the Quality Control Department of ABC Pharmaceuticals, City
3. Responsibility: Quality Control Chemist
4. Accountability: Quality Control Manager
5. Abbreviations :
S.O.P.: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
6. Procedure SOP for supervision of Analysis:
6.1 Spot check once a week all registers, reagents, and reference standard solutions.
6.2 Frequently observe the actual testing done by the chemist staff.
6.3 Review analytical reports and before singing check and confirm for :
a. Completeness of all entries.
b. Whether analysis has been done, and confirm that it has been performed as per the specified pharmacopeia or in-house specifications (if specified).
c. If not found to comply, the section head should bring to the attention of the QC in charge / senior QC personnel so that necessary action to rectify/modify the procedure can be taken.
6.4 The respective section head must scrutinize for completeness all entries to date. Reagents should be stored in bottles.
6.5 Reference standard solution, reference standards stored in the desiccator should be checked for details like name, the solvent used wherever applicable, date of preparation, date of expiry, the signature of the person preparing.
6.6 Regents found to be having sedimentation etc. should be destroyed and the shelf-life period should be reviewed to prevent a recurrence.
6.7 The respective section heads must observe in person, the work carried out by the chemist staff so that feedback on the followed, planning of work, accuracy, precision, and efficiency in their can be enhanced.
The author has 20 years of experience in the Pharmaceutical Manufacturing Companies. Have exposure to all audit documents for WHO-GMP, PIC/S, USFDA, Export documents, US-FDA documents, Validation of Pharma machinery, and Quality Control Instruments. Expert in Pharma Plant Setup and sale and acquisition of running pharma company.