| SOP for Gap Analysis |
1.0 OBJECTIVE To lay down the procedure for find out the gap between the company policies and procedure with the statutory and regulatory guidelines. 2.0 SCOPE This procedure is applicable for all policies and procedure followed SOP for Gap analysis. This procedure is also applicable for the validation/qualification protocols/reports, test procedures, executed documents including apex documents such as Site Master File (SMF), Validation Master Plan (VMP), CVMP and SHE manual but not limited to. 3.0 RESPONSIBILITY • Executive and above of concerned department • Head of Department 4.0 ACCOUNTABILITY Head Quality / QA To Read SOP for Visual Inspection in Sterile Bulk & Formulation Click Here 5.0 PROCEDURE 5.1 Gap analysis shall be done to identify the gap between the company policies and procedure with relevant regulatory guidelines to make the company policies and procedure in compliance. 5.2 Whenever any new guideline is published or any pharmacopoeia procedure is revised or updated the gap analysis shall be done. 5.3 Gap analysis shall be done as per format no. XXX and compliance details shall be recorded. If anything found not available in XXX policies/ procedures as per guideline and same is applicable to XXX, the proposed action plan and target completion date (TCD) shall be given. 5.4 On completion of gap analysis report, same shall be submitted to QA department for review and subsequently to Head QA for approval. 5.5 After approval and recommendation from Head QA the documents shall be revised/ updated as per change control procedure as per SOP No. XXX. 5.6 During gap analysis if found any policy or procedure is not available, new document shall be prepared to address the same. 5.7 The gap analysis activity shall not be limited to publication of any guideline or pharmacopoeial update, but could be done to review and verify the correctness and compliance status of executed and archived documents. |
