PRODUCT DETAIL PROCESS VALIDATION PROTOCOL & REPORT CONCURRENT PROCESS VALIDATION FOR RABEPRAZOLE EC AND DOMPERIDONE SR CAPSULES GENERIC NAME: Rabeprazole EC and Domperidone SR Capsules LABEL CLAIM: Each Hard Gelatin Capsule contains:- Rabeprazole Sodium IP 20 mg (As Enteric Coated Pellets) Domperidone IP 30 mg (As sustained release pellets) BATCH DETAIL: Sr. No. Product Name … Read more
Validation for cleaning procedure liquid injection SCOPE OF VALIDATION LIQUID INJECTION PROTOCOL NO. SUPERSEDES EFFECTIVE DATE TABLE OF CONTENTS Sr. No. SECTION TITLE PAGE No. 1.0 PROTOCOL APPROVAL 2.0 OVERVIEW 2.1 OBJECTIVE 2.2 PURPOSE 2.3 SCOPE 2.4 RESPONSIBILITY 2.5 REVALIDATION 2.6 CLEANING TYPES EQUIPMENT DETAILS EXPERIMENTAL PLAN – CLEANING PROCEDURE CHECK LIST FOR CLEANING … Read more
Validation for cleaning procedure dry powder injection SCOPE OF VALIDATION DRY POWDER INJECTION PROTOCOL NO. SUPERSEDES EFFECTIVE DATE 15-03-2012 TABLE OF CONTENTS Sr. No. SECTION TITLE PAGE No. 1.0 PROTOCOL APPROVAL 2.0 OVERVIEW 2.1 OBJECTIVE 2.2 PURPOSE 2.3 SCOPE 2.4 RESPONSIBILITY 2.5 REVALIDATION 2.6 CLEANING TYPES 2.7 APPROACH 2.8 EXECUTION OF PLANNING 3.0 CLEANING … Read more
sop for Training of Plant Personnel REVISION SUMMARY Version Number Date Revised Reason for Revision 00 Effective Date : First Issue 01 Effective Date : Incorporation of Qualification, Questionnaire and Evaluation Criteria of employee. 1.0 OBJECTIVE 1.1 To organize and conduct training program to all the plant employees at all levels. 2.0 … Read more
sop for vendor approval of raw materials 1.0 OBJECTIVE: : 1.1 The objective of this SOP is: 1.1.1. To describe a procedure to assess the vendors who can manufacture and supply materials of consistent quality and quantity and at right time 2.0 RESPONSIBILITY: 2.1 The Head – Quality Assurance shall be: 2.1.1. Responsible for auditing … Read more
sop for handling of non conformance incidence 1.0. OBJECTIVE: The objective of this SOP is: 1.1 This procedure defines the responsibilities and authority for handling and investigating non-conformance (NC), for taking appropriate corrective and preventive actions to prevent recurrence of the same. 2.0. RESPONSIBILITY: 2.1 Any employee of the organization shall be: 2.1.1 Responsible … Read more
sop for self inspection and internal audit for quality 1.0 OBJECTIVE: The objective of this SOP is: 1.1 To laid down the procedure to conduct self-inspection (Internal Audit) in order to monitor the implementation and compliance with Good Manufacturing Practices (GMP), Principles and to propose necessary corrective measures. 2.0 RESPONSIBILITY: 2.1 The … Read more
sop for area and equipment clearance procedure OBJECTIVE: 1.0 To describe the procedure for checking of equipment and area before giving line clearance during manufacturing and packaging operation. 2.0 RESPONSIBILITIES: 2.1 Quality Assurance – Officer/ Executive shall be: 2.1.1 Responsible for assuring the equipment and area for free from remnant of previous batch / … Read more
1.0 OBJECTIVE: The objective of this SOP is: 1.1 To describe a procedure for allowing transfer of Finished Goods under “Quarantined status” to our godown. 2.0 RESPONSIBILITY: 2.1 The Head – Warehouse shall be: 2.1.1 Responsible for raising the request for Quarantined Release. 2.2 Quality Assurance Officer shall be: 2.2.1 Responsible for verification and reconciliation … Read more
1.0 OBJECTIVE 1.1 To lay down the detailed procedure for the Validation of Analytical Methods / Procedures. 2.0 SCOPE 2.1 This Procedure is applicable for the Validation of Analytical Methods being executed using Chromatographic Systems (For Assay, Related Substances, Residual Solvents, Chromatographic Purity, and Content Uniformity etc.), Rate, Particle Size, Viscosity etc. in the Quality … Read more