SOP on Additional testing
Objective: To lay down a procedure to carry out additional testing after necessary QA approval so as to avoid unwanted testing and analysis.
Scope: This procedure is applicable to any additional testing required for confirmation or investigation.
The additional testing may be required for finished products, Intermediate products, Raw Materials and Packing materials.
Responsibility:
Personnel- QC- Raise the additional testing form.
Head-QC / nominee – Justify additional testing and approve the additional testing form.
Head – QA / nominee – Approval of additional testing.
Personnel- QA /QC – To issue the samples.
Accountability:
Head – QC / Head – QA shall be accountable for compliance and implementation of the SOP.
Procedure:
Additional testing shall be carried out in any of the following cases
On receipt of any Product complaint.
If any out of Trend results are encountered.
Incase if the Pharmacopoeial status of existing raw material needs to be converted to another pharmacopoeia.
If Out of specification investigation demands additional testing.
To respond to regulatory queries.
In any other circumstances where additional testing can be justified.
Following procedure shall be followed to perform additional testing:
QC person shall fill the additional testing form as mentioned.
QC head shall provide justification for additional testing and approve the additional testing form.
QA head shall finally review and approve the additional testing.
After final approval, concern QA/ QC person shall issue the required quantity of samples for testing.