1.0 OBJECTIVE
1.1 To lay down a procedure for Analytical Chemist Validation.
2.0 SCOPE
2.1 This procedure applies to the Pharmaceutical Manufacturing Facility of__________
3.0 RESPONSIBILITY
3.1 Chemists – Quality Control
4.0 ACCOUNTABILITY
4.1 Head – Quality Control
5.0 PROCEDURE
5.1 Analyst qualification is applicable in the following cases:
5.1.1 Qualification of the new analyst
5.1.2 Qualification of the regular analyst
5.2 All-new analysts will be qualified before independently handling the analysis.
5.3 Regular analyst qualification is conducted periodically by using already approved samples and conformity of test results with standard specification as acceptance limit.
5.4 New analyst qualification involves the triplicate analysis of the same sample and conformity of the test results with the acceptance limit.
5.5 Regular analyst qualification involves the analysis of the sample by the concerned person. The results shall be compared and counter checked with the original test results/ specification of the sample.
5.6 Identify the sample to be tested (already approved), AR No, Acceptance limit, and give the code number for identity.
5.7 Sample shall be given to analyst inappropriately coded polythene bags/Glass bottles as applicable.
5.8 The necessary information required for the analysis of coded samples shall be disclosed to the analyst.
5.9 Analyst qualification shall include assay, dissolution, moisture content, and other physical parameters like disintegration test, etc., as required.
5.10 The Qualification of analyst shall be assessed in terms of the following
5.10.1 Results are within the acceptable limits as per Table – IA, IB, IC.
5.10.2 Analyst complies with GLP practices.
5.10.3 Document the results as per requirement.
5.11 Analyst qualification is performed once a year or as per the requirement.
5.12 Record the analyst qualification as per Annexure: 1.
5.13 Incase the analyst did not qualify, he/she shall be retrained and shall not be allowed for the subject work till he/she is qualified for the task.
5.14 All analyst qualification records are archived in Quality Control.
Table-1 A
Test | Acceptance Criteria |
Assay by HPLC | RSD NMT 1.0% Individual & within the group |
Absorbance by UV | RSD NMT 1.0% Individual & within the group |
Water by KF | RSD NMT 1.0% Individual & within the group |
Assay by titrimetry | RSD NMT 1.0% Individual & within the group |
SOR by polarimeter | RSD NMT 1.0% Individual & within the group |
RSD NMT 1.0% | |
RSD NMT 1.0% |
Note: All results /individual test values should be within the specification of the test product.
Table-1 B
In the case of Assessment by RSD (Relative Standard deviation), as applicable, follow the table below.
S. No | % of Active ingredient | Test | RSD Limit |
1 | Assay | 1 | |
2 | 10 – 100 mg | Assay | 2 |
3 | 1 – 10 mg | Assay | 3 |
4 | >1 mg | Assay | 4 |
Table-1 C
S. No | % of Active ingredient | Test | RSD Limit |
1 | Dissolution | 1 | |
2 | 10 – 100 mg | Dissolution | 3 |
3 | 1 – 10 mg | Dissolution | 5 |
4 | < 1 mg | Dissolution | 10 |
Note: RSD limits are in-house.
6.0 ABBREVIATIONS
6.1 SOR-Specific Optical Rotation
6.2 HPLC – High-Performance Liquid Chromatography
6.3 KF – Karl Fischer
6.4 RSD – Relative Standard Deviation
6.5 NMT – Not more than
6.7 GLP – Good Laboratory Practice
6.8 QA - Quality Assurance
7.0 REFERENCES
7.1 Nil.
8.0 ANNEXURES
8.1 Annexure: 1 – Analytical Chemist Validation Data Sheet
END OF THE DOCUMENT
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