Sop cleaning of uniform 1. PURPOSE & SCOPE: To laydown the procedure for cleaning of uniform. 2. RESPONSIBILITY Personnel officer 3. AUTHORITY Factory manager 4. PROCEDURE The following uniforms are used in the plant. A. Smoke coat for all production and packing Workers/Officers/Managers. B. Aprons for all the Supervisor/Officers/Managers and Q.C.D. Staff. C. … Read more
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 procedure for work permit 1.0. OBJECTIVE: The objective of this SOP is: 1.1 To describe the procedure for getting permission for work permit. 2.0. RESPONSIBILITY: 2.1 The Initiator – The Head – Engineering /Concern department (however engineering department is not involved) shall be: 2.1.1 Responsible for filling up of Work Permit … Read more
sop for operation of barcode scanner 1.0 OBJECTIVE: 1.1. The purpose of this SOP is: 1.1.1. To describe the procedure for operating the Bar Code scanner. 2.0 RESPONSIBILITY: 2.1 The Chemist / Officer – Quality Control Packaging shall be: 2.1.1. Responsible for operating the bar code scanner as per the procedure. 3.0 ACCOUNTABILITY: … Read more
sop for operation of pin hole tester 1.0. OBJECTIVE: The objective of this SOP is: 1.1 To describe the procedure for testing of the number of pinholes. 2.0. RESPONSIBILITY: 2.1 The Chemist – Quality Control Packaging 2.1.1. Responsible for carrying out the testing as per procedure. 2.1.2. Responsible for recording of observations in … Read more
Sop for certification of authorised sterile entry 1.0 OBJECTIVE: The objective of this SOP is: 1.1 To describe the procedure for Authorization and control of persons for entry to sterile area. 1.2 This is applicable for production Operators, Staffs, Q.C., Q.A. and Maintenance persons. 2.0 RESPONSIBILITIES: 2.1 Concerned Operator shall be: 2.1.1 Responsible … Read more
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