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Production

Manufacturing Facility in Pharmaceuticals Industry have different type & Section that we explain here

Maintaining Machine Usage Log

Maintaining Machine Usage Log

Production
The Standard Operating Procedure of Maintaining Machine Usage Log is described in this post. Maintaining Machine Usage Log OBJECTIVE 1.1 To lay down the procedure for maintaining machine or equipment usage log. SCOPE 2.1 The scope of this SOP pertains to maintaining machine usage log of all machines or equipments placed in Production or Quality Area. RESPONSIBILITIES 3.1 It is the responsibility of Operator and section Supervisor to follow this SOP as it is written. 3.2 It is the responsibility of Production Pharmacist, Quality Control Analyst and Quality Assurance Officer to ensure that this SOP is followed as it is written. 3.3 It is the responsibility of Production Manager to make certain that this SOP is followed in its entirety, reviewed and updated as necessary. DEFINITI...
Operation Of Paste Cooking Kettle

Operation Of Paste Cooking Kettle

Production
In this post procedure of operation Of Paste Cooking Kettle is describe as given below Operation Of Paste Cooking Kettle OBJECTIVE 1.1 To describe procedures for the operation of Steam Jacket Kettle. SCOPE 2.1 This SOP applies to the operational procedure of Steam Jacket Kettle. RESPONSIBILITIES 3.1 It is the responsibility of steam jacket kettle Supervisor (Liquid manufacturing) to follow this SOP as it is written. 3.2 It is the responsibility of Production Pharmacist (Oral Liquids), to ensure that this SOP is followed as it is written. 3.3 It is the responsibility of Senior Production Manager to make certain that this SOP is followed in its entirety, review and update as necessary. DEFINITIONS& ABBREVIATIONS NA MATERIALS & EQUIPMENTS NA PROCEDURE 6.1 Open the dr...
Cleaning Of Paste Cooking Kettle

Cleaning Of Paste Cooking Kettle

Production
Cleaning Of Paste Cooking Kettle is fully described in this post which helps you to clean the kettle. Cooking kettle is widely used in Pharmaceuticals industry so If you're going to be a part of Pharma then you should read this knowledge-based article about Cleaning Of Paste Cooking Kettle/ Cleaning Of Paste Cooking Kettle OBJECTIVE 1.1 To describe procedures for the cleaning of paste cooking Kettle. SCOPE 2.1 This SOP is applicable for the cleaning of the paste cooking Kettle in the tablet Section in the Production Department. RESPONSIBILITIES 3.1 It is the responsibility of section Supervisor to follow this SOP as it is written. 3.2 It is the responsibility of Production Pharmacist (tablet section) to ensure that this SOP is followed as it is written. 3.3 It is the responsibi...
Training in Pharmaceuticals Industries

Training in Pharmaceuticals Industries

Production
In this post the complete detail is given about Training in Pharmaceuticals Industries, which help to personnel work-friendly in the pharmaceuticals industry. Training in Pharmaceuticals Industries OBJECTIVE 1.1. The purpose of this SOP is to describe the procedure for Training in Pharmaceuticals Industries of the personnel working under cGMP environment at Pharmaceutical. SCOPE 2.1. The scope of this Training in Pharmaceuticals Industries SOP pertains to all the persons working at Pharmaceutical. RESPONSIBILITY 3.1. It is the responsibility of departmental heads to follow this SOP as it is written. 3.2. It is the responsibility of QA to ensure that all employees have been trained and qualified in their respective job functions, regulatory and compliance procedures and safety regula...

Destruction Of Expired and Rejected Material

Production
Destruction Of Expired and Rejected Material SOP is described in this blogpost. PURPOSE: This procedure is established to destroy Expired Raw Materials, Expired & Rejected Returned Stock, Rejected In-process products, Rejected Packaging Components and obsolete records & documents. Responsibility: Warehouse Incharge, QC/QA Manager, Plant Manager and Chief Executive Officer. Procedure: Destruction is to be carried out semiannually preferably in the month of January & July of every year or when ever required. Segregate and Collected the Items as under:- 1. All rejected Raw Material (Active & non Active. 2. All Rejected inprocess products batches. 3. All Returned and Rejected Finished Stock from market & production. 4. All Rejected Packaging Components and o...

Returned Goods Handling

Production
Returned Goods Handling is described in this blogpost that help to handle of return goods OBJECTIVE: To describe the procedure for returned goods received from distributors/market. PROCEDURE: i) Returned goods received from Distributors will be received on a document. ii) This stock will be sorted out and segregated into 4 categories Category No.1 Stock can be reused if having reasonable shelf life at least more than six months after checking from Q.C. and redressing if required. Category No.2 If left over shelf life is between 3-6 months it will be converted to Physician sample after Q.C. checking. Category No.3 If the shelf life is below three months, it can be donated to any running clinic, or charity organization after checking from Q.C. and redressing if required, with fina...

Retaining Of Sample Of Finished Goods

Production
In this blog we come to know how to retaining of sample of finished Goods in pharmaceuticals industry. Retaining Of Sample Of Finished GoodsOBJECTIVE 1.1 To lay down the procedure for retaining of sample. SCOPE 2.1 The scope of this SOP applies to the procedure for retaining of sample of a product from packing line in packaging section of production department. RESPONSIBILITIES 3.1 It is the responsibility of Line Supervisors (packaging) to follow this SOP as it is written. 3.2 It is the responsibility of Production Pharmacist (packaging) to ensure that this SOP is followed as it is written. 3.3 It is the responsibility of Production Manager to ensure that this SOP is followed in its entirety, reviewed and updated as necessary. DEFINITIONS & ABBREVIATIONS 4.1 SOP: Standar...

Batch Stamp Preparation SOP in Pharma

Production
In pharmaceutical industry Batch Stamp Preparation SOP is used for printing on unit carton, label etc Batch Stamp Preparation OBJECTIVE 1.1 To lay down the procedure for making batch stamp. SCOPE 2.1 The scope of this SOP pertains to procedure for making batch stamp. RESPONSIBILITIES 3.1 It is the responsibility of Production Pharmacist (packing) to ensure that this SOP is followed as it is written. 3.2 It is the responsibility of Production Manager, to ensure that this SOP is followed in its entirety, reviewed and update as necessary. DEFINITIONS & ABBREVIATIONS 4.1 SOP: Standard Operating Procedure 4.2 BPR: Batch Processing Record MATERIALS & EQUIPMENTS NA PROCEDURES 6.1 Confirm batch number from batch order. 6.2 Confirm manufacturing date from final release ...
Assigning Work To Various Workers On A Line For Packaging

Assigning Work To Various Workers On A Line For Packaging

Production
Assigning Work To Various Workers On A Line For Packaging SOP is created for the Production area of pharmaceuticals. Assigning Work To Various Workers On A Line For Packaging OBJECTIVE 1.1 To assign the work to various workers on a line for packaging. SCOPE 2.1 The scope of this SOP applies to assign work to various workers on a packing line in packaging section of production department. RESPONSIBILITIES 3.1 It is the responsibility of packing line Supervisor (packaging) to follow this SOP as it is written. 3.2 It is the responsibility of Production Pharmacist (packaging) to ensure that this SOP is followed as it is written. 3.3 It is the responsibility of Production Manager, to ensure that this SOP is followed in its entirety, reviewed and update as necessary. DEFINITIONS...
Packing Of Tablets And Capsules In Packaging Section

Packing Of Tablets And Capsules In Packaging Section

Production
In this post completely explained about Packing Of Tablets And Capsules In Packaging Section in pharma. Packing Of Tablets And Capsules In Packaging Section OBJECTIVE 1.1 To describe the procedure for packing of tablets and capsules in packaging section. SCOPE 2.1 The scope of this SOP applies to packaging of tablets and capsules in packaging section of production department. RESPONSIBILITIES 3.1 It is the responsibility of Line Supervisor (packaging) to follow this Packing Of Tablets And Capsules In Packaging Section SOP as it is written. 3.2 It is the responsibility of Packaging Pharmacist to ensure that this Packing Of Tablets And Capsules In Packaging Section SOP is followed as it is written. 3.3 It is the responsibility of Production Manager, to ensure that this SOP is...