Sop batch demarcation and batch coding 1. PURPOSE & SCOPE To laydown the procedure for batch demarcation and batch coding. 2. RESPONSIBILITY Production officer 3. AUTHORITY Production manager 4. PROCEDURE Batch size for different dosage forms are determined on the basis of following parameters : 1. Uncoated Tablet – mixing capacity and blending … Read more
Standard operating procedure material receipts 1. PURPOSE & SCOPE: To laydown the procedure for material receipts. 2. RESPONSIBILITY: Store Keeper 3. AUTHORITY Store Incharge 4. PROCEDURE 1. All the incoming material is received at the factory gate. The Security Supervisor undertakes the following operation: a) Checks the number of backs written on the … 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 in-process control on liquids orals 1.0 OBJECTIVE To ensure quality of product during Washing, Filling, Sealing, Inspection, Labeling and packaging operation of Liquid Orals. 2.0 RESPONSIBILITY Quality Assurance Officer 3.0 ACCOUNTABILITY Quality Assurance Manager. 4.0 PROCEDURE 4.1 START UP Washing / Filling / Sealing and Inspection 4.1.1 Ensure that the … Read more
sop for in process controls on tablets capsules packaging line 1.0 OBJECTIVE: The objective of this SOP is: 1.1 To describe the procedure for monitoring the Quality of products during blister or strip sealing, bulk filling and packaging operation of capsules or tablets. 2.0 RESPONSIBILITIES 2.1 Quality Assurance Officer shall be: 2.1.1 … Read more
sop for Issuance retrieval and destruction of BMR and analytical records 1.0 OBJECTIVE The objective of this SOP is: 1.1 To lay down a procedure for issuance, Storage, Retrieval and Destruction of BMR and Control Records. 2.0 RESPONSIBILITY 2.1 Officer / Executive – Quality Assurance (QA) shall be: 2.1.1. Responsible for issuing a … Read more
sop for in process controls during granulation compression coating inspection 1.0 OBJECTIVE: The objective of this SOP is: 1.1 To describe the procedure for monitoring the Quality of Tablets during granulation, compression, coating, inspection operation. 2.0 RESPONSIBILITIES: 2.1 Quality Assurance Officer / Executive shall be: 2.1.1 Responsible for assuring the quality of … Read more
sop for Cleaning of Blister packing machine 1.0 OBJECTIVE : • To lay down a procedure for Cleaning of Blister packing machine 2.0 SCOPE : • This procedure is applicable for Cleaning of Blister packing machine for production 3.0 RESPONSIBILITY: • Operator – To perform the procedure. Head Officer • Production: Officer … Read more
sop for for charge hand over between the shifts 1.0 OBJECTIVE: To lay down a procedure for charge hand over between the shifts 2.0 SCOPE: This Standard Operating Procedure is applicable for charge hand over between the shifts production department. 3.0 RESPONSIBILITY: Operator – To perform the procedure. Head Officer production- To ensure … Read more
Performance requalification report of visual inspectors REPORT CONTENTS SERIAL NO. SECTION TITLE 1.0 Report Approval 2.0 Summary Plan of Study 3.0 Description of Operating conditions 4.0 Results, Discussion and Conclusion 5.0 Deficiencies Observed and Corrective Action Taken 6.0 Annexure reports 1.0 PROTOCOL APPROVAL Designation Signature Date Prepared By … Read more