sop for man and material entry procedure to the raw material sampling area 1.0. OBJECTIVE: The objective of this SOP is: 1.1 To describe the procedure for gowning and de gowning in the Raw material sampling room. 2.0. RESPONSIBILITY: 2.1 The QC Officer shall be: 2.1.1. Responsible for ensuring the following up of … Read more
sop for annual quality review 1.0 OBJECTIVE To lay down a procedure to review all parameters which affect the quality and safety of products annually and decide the remedial actions for improvements. 2.0 RESPONSIBILITY Quality Assurance Executive 3.0 ACCOUNTABILITY Head – Assurance 4.0 PROCEDURE Introduction: Total number of batches manufactured in … Read more
sop for Vendor approval of packaging 1.0 OBJECTIVE: 1.1 The objective of this SOP is: 1.1.1. To describe a clear guideline for approval of new vendor of Packaging Materials. 2.0 RESPONSIBILITY: 2.1 The Quality Assurance shall be: 2.1.1. Responsible for auditing the vendor for cGMP Compliance periodically in co-ordination with Head – Materials. … Read more
sop for monitoring of raw potable and reverse osmosis water 1.0 OBJECTIVE: The objective of this SOP is: 1.1 To lay down a procedure for monitoring of Raw and potable water. 2.0 RESPONSIBILITY: 2.1 The Microbiologist shall be: 2.1.1 Responsible for sampling and analysis 2.2 The IPQA personnel shall be : 2.2.1 … Read more
sop for cleaning of QC laboratory 1.0 OBJECTIVE To lay down the procedure for cleaning of quality control laboratory. 2.0 RESPONSIBILITY Hygiene supervisor 3.0 ACCOUNTABILITY Quality Control Officer. 4.0 PROCEDURE FOR GENERAL CLEANING 4.1 Broom the floor of all the sections including the staircase, daily and then mope with wet mope. 4.2 Clean … Read more
procedure for checking the correctness of the computerised formulation order issue system 1.0 OBJECTIVE To lay down the procedure for checking correctness of the computerized formulation order issue system. 2.0 RESPONSIBILITY Production Planning / Quality Control officer 3.0 ACCOUNTABILITY Production Planning Manager / Quality Assurance Manager 4.0 PROCEDURE 4.1 Print computerized Formulation Order. … Read more
sop for monitoring of reprocessing of products 1.0 OBJECTIVE To lay down the procedure for monitoring of Reprocessing of product. 2.0 RESPONSIBILITY Quality Control Officer / Quality Assurance Officer. 3.0 ACCOUNTABILITY Quality Assurance Manager 4.0 PROCEDURE 4.1 Procedure of reprocessing is applicable to products for domestic market. No reprocessing shall be carried for … Read more
Sop for Sticker Label 1.0 OBJECTIVE 1.1 To lay down a procedure for Analysis of sticker labels. 2.0 SCOPE 2.1 This procedure is applicable to the Analysis of sticker labels in QC laboratories 3.0 RESPONSIBILITY 3.1 Q.C- Chemist 4.0 ACCOUNTABILITY 4.1 Head-Quality Assurance 5.0 DESCRIPTION:– Visually check the appearance of the sample like … Read more
sop for Laboratory discipline 1.0 OBJECTIVE To lay down the discipline of those persons operating within the quality control laboratory. 2.0 RESPONSIBILITY Chemist/ Executive 3.0 ACCOUNTABILITY Manager Q.C 4.0 PROCEDURE 4.1 Laboratory operators must work under supervision unless they have satisfactorily demonstrated their Competence with respect to the specific operation. 4.2 Analytical Procedure … Read more
Procedure for review and approval of analytical raw data 1.0 OBJECTIVE To lay down a procedure for review and approval of Analytical Raw Data 2.0 RESPONSIBILITY Quality Control Chemist / Quality Control Executive 3.0 ACCOUNTABILITY Quality Control Manager 4.0 PROCEDURE 4.1 The reviewer shall ensure the following at the time of reviewal of … Read more