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 Control
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 …
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 …
SOP FOR CORRECTIVE AND PREVENTIVE ACTION
1.0 OBJECTIVE To lay down the procedure to be followed for the administration of corrective and preventive actions (CAPA) including tracking and reporting 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 …
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 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. …
SOP for operation & calibration of Disintegration Test Apparatus
OBJECTIVE: To lay down a procedure for Operation & Calibration of Disintegration test apparatus. SCOPE: This procedure is applicable for procedure for Operation & Calibration …
Audit / Engineering / GMP / Microbiology / Production / Quality Assurance / Quality Control / SOPs / Store / Ware house / Uncategorized
SOP FOR HANDLING OF CHANGE CONTROL
OBJECTIVE To lay down a procedure to describe the handling of change control which include the procedure for initiation, evaluation, review, approval/ rejection of proposed …
Audit / Engineering / GMP / Microbiology / Quality Assurance / Quality Control / SOPs / Store / Ware house
SOP FOR HANDLING OF DEVIATION
OBJECTIVE To describe the procedure for handling of deviations. 2.0 SCOPE This SOP is applicable for any deviation in an established process in all …