Sop for equipment assembly

  Sop for equipment assembly   1. OBJECTIVE: To issue a procedure for assembly, disassembly and reassembly of equipment after operation, cleaning etc. 2. RESPONSIBILITY Production Officer Production Manager 3. AUTHORITY Q. A. Manager 4 PROCEDURE 1. Prepare a checklist of all the parts and match it with equipment. 2. After operation of the machine, … Read more

sop for operation of capsule loading machine semi automatic

  sop for operation of capsule loading machine semi-automatic   1. PURPOSE & SCOPE To lay down guidelines for operation of capsule loading Machine . 2. RESPONSIBILITY Production Officer 3. AUTHORITY Production Manager 4. PROCEDURE Machine Name : CAPSULE LOADING MACHINE M/C No. :___ The entire Machine Operation is divided in three stages :- i) … Read more

sop for retrospective validation of process or process equipment

  sop for retrospective validation of process or process equipment 1. OBJECTIVE: To implement a method of validation of process and process equipment’s already in operation. 2. RESPONSIBILITY Production supervisor QA supervisor 3. AUTHORITY Production manager QA manager 4. PROCEDURE: 1. Take five batches data for observation of the process parameter e.g. mixing in mass … Read more

Sop for material reconciliation and return

  Sop for material reconciliation and return 1. OBJECTIVE: To lay down the procedure and methods for reconciliation of issued material and returning of the material left unused, responsibility for implementation the procedure and records to be maintained for conformity with GMP requirements. 2. RESPONSIBILITY Production supervisor QA supervisor 3. AUTHORITY Production manager QA manager … Read more

Sop for handling of returned products

Sop for handling of returned products 1. OBJECTIVE To lay down the procedure & methods to handle the product returned to ware -house for any reason, its disposition, responsibility for implementation of the procedure and records to be maintained. 2. RESPONSIBILITY Production supervisor QA supervisor 3. AUTHORITY Production manager QA manager 4. PROCEDURE 1. Isolate … Read more

sop for Machine operation capsule inspection and polishing machine

  sop for Machine operation capsule inspection and polishing machine   1. PURPOSE & SCOPE : To lay down guidelines for operation of capsule Filling machine. 2. RESPONSIBILITY Production Officer 3. AUTHORITY Production manager 4. PROCEDURE : MACHINE NAME: Semi automatic Capsule Filling Machine M/C No.:——- The entire Machine Operation is divided in three stages … Read more

Sop for issue of material

  Sop for issue of material 1. PURPOSE & SCOPE: To laydown the procedure for issue of materials. 2. RESPONSIBILITY Store keeper 3. AUTHORITY Store incharge 4. PROCEDURE 1. Any material whether raw or packing material are to be issued against requisition raised by the store indenting department. 2. The material requisition is raised in … Read more

Sop cleaning of uniform

  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

  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

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