sop on operation and cleaning of coating pan 1.0 Objective: To describe the procedure for operation and cleaning of coating pan. 2.0 Scope: This procedure is applicable to coating pan 3.0 Responsibility: Operator / Production Officer / Executive 4.0 Accountability: Department Head shall be accountable for the compliance of the system. 5.0 … Read more
sop of Deviation in batch size 1. OBJECTIVE : To issue a procedure for deviation of batch size from master formula required to match demand and supply. 2. RESPONSIBILITY QA Manager Production Manager 3. PROCEDURE : a. Divide the order quantity in standard batch size and produce as many full batch possible out … Read more
sop for Operation of cleaning of pipe lines 1. PURPOSE & SCOPE : To lay down the procedure for operation of cleaning of pipe carrying purified water. 2. RESPONSIBILITY : Production Officer 3. AUTHORITY : Q.A. Manager 4. PROCEDURE The sanitation of pipes of carrying water is very essential work for a Pharmaceutical … Read more
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 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 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 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 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 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 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