SOP FOR PROCESS VALIDATION
by OBJECTIVE To lay down a procedure for minimum requirement for validation or revalidation of manufacturing process applicable to marketed drug products in order to provide …
Category: Quality Assurance
SOP FOR GOOD DOCUMENTATION PRACTICE
0 OBJECTIVE To lay down a procedure for good documentation practice in quality assurance, quality control, production and other departments. 2.0 SCOPE This SOP is …
Hold time study of pharmaceutical products during manufacturing
1.0 OBJECTIVE To lay down the procedure for conducting the hold time study of pharmaceutical products during manufacturing at every stage of In – process …
APPROVAL OF ARTWORK
1.0 OBJECTIVE To lay down a procedure for the preparation and approval of art works 2.0 SCOPE This SOP is applicable for approval of …
RELEASE OF FINISHED GOODS
1.0 OBJECTIVE To provide guidelines for release of finished products for sale and distribution. 2.0 SCOPE 2.1 This SOP is applicable for release of …
HANDLING OF BATCH MANUFACTURING DOCUMENT ISSUANCE AND RECEIPT
1.0 OBJECTIVE To provide guideline for Issue, Receipt and Storage of Batch Manufacturing documents. 2.0 SCOPE This SOP is applicable for Issue, receipt …
RESPONSIBILITIES OF QUALITY ASSURANCE PERSONNEL
1.0 OBJECTIVE This SOP gives the responsibilities of Quality Assurance (QA) personnel. 2.0 SCOPE This SOP is applicable for QA department. 3.0 RESPONSIBILITY …
SELF INSPECTION
OBJECTIVE : To provide a guideline for self-inspection of facility by a team of qualified persons to monitor the implementation and compliance with Good Manufacturing …
SOP ON SIGNATURE AUTHORIZATION
1.0 OBJECTIVE To describe the procedure for Signature Authorization. 2.0 SCOPE This procedure is applicable for the preparation of QMS & other …
SOP FOR OUT OF SPECIFICATION RESULTS
To lay down the procedure for investigation of Out of Specification (OOS) test result(s) of Finished Products, Stability Samples, Raw Materials & Packing Materials etc. …