Production - Pharma Egg

Jan292023 by KBS.No Comments

Air Changes and Product Data Analysis

Air Changes and Product Data Analysis uses in Pharmaceuticals is the use and application of data analytics in the pharmaceutical industry. Integrating big data analytics solutions into pharmaceutical manufacturing processes allows companies to gain valuable insights to accelerate and optimize production. Standard operating procedure Air Changes and Product Data Analysis to measure the air velocity and air changes per hour in CFM in classified area. The measured air quantity shall not be less than the designed air quantity and the calculated air changes shall not be less than the designed air changes per hour. Objective :- To ensure the air changes in sterile areas (clean Room) as per specification and To analyses product related data for conformance to specifications, determ...

Jan262023 by KBS.No Comments

SOP for Sanitation in Pharmaceuticals

Production, General Topics

This applies to the general area, tablet production area, manufacturing area, compression/packaging area, clean area, and pharmaceutical cleaning frequency. Procedures for transferring cleaning agents and disinfectants into and out of clean areas (including procedures for disinfection of disinfectants). SOP for Sanitation in Pharmaceuticals stands for cleaning using the dryer. Cleaning the entire floor using a 2.5% disinfectant solution. (disinfectant) Coving, corner cleaning of the entire area using a wet mop. Clean the tube light fixture using a wet mop followed by a clean dry mop. PURPOSE : To lay down the procedure for sanitation in Pharmaceuticals. SCOPE: This is applicable to the general area, tablet production area, manufacturing area, compression/packaging area, clean area, &am...

Jan262023 by KBS.No Comments

SOP for Production Planning and Batch Record Review

Production

This SOP for Production Planning and Batch Record Review is for assigning individual responsibilities to Q.A and Production with regard to proper entries and completion of batch records in time to ensure batch product release. This SOP for Production Planning and Batch Record Review the documented procedure for points to be checked by QA during batch record review. PURPOSE: To describe the procedure for production planning and batch record review. SCOPE: This procedure is for Quarterly / Monthly & Fortnightly / Weekly production planning of all sections of the Production Department and the documented procedure for points to be checked by QA during batch record review. RESPONSIBILITY: Production Manager. Production Pharmacist. Head of the Production Department REFERENCES: In...

Jan262023 by KBS.No Comments

SOP for the Manual Capsule Machine Operation and Cleaning

Production, General Topics

SOP for the Manual Capsule Machine Operation and Cleaning is split up into 2 main types, semi-automatic and fully automatic. Semi-automatic machines require the operator to assist with production by moving the filling plates between the different production stages. SOP for the Manual Capsule Machine Operation and Cleaning the end of the day or product, changeover remove any visible material from the machine with the help of a nylon brush, vacuum cleaner, and jet of compressed air. PURPOSE: To lay down the operating procedure for the Operation and cleaning of the Manual cap machine. SCOPE: This shall be applicable to the operation and Cleaning of Manual Capsule machines in the area of Production. RESPONSIBILITY: Supervisor/ Machine Operator. Production Pharmacist. Manager-Pr...

Jan242023 by KBS.No Comments

SOP for Tablet Compression and Granulation

Production, General Topics

SOP for Tablet Compression and Granulation, the process of particle enlargement by agglomeration technique, is one of the most significant unit operations in the production of pharmaceutical dosage forms, mostly tablets and capsules. SOP for Tablet Compression and Granulation process transforms fine powders into free-flowing, dust-free granules that are easy to compress. PURPOSE: To lay down the procedure for Tablet Compression and Tablet Granulation. SCOPE: This SOP is for all the processes from compression including the changeover for the next batch at the Production department and granulation including processing for the next batch at the Production department. RESPONSIBILITY: Execution: Operator. Checking: Production Pharmacist. REFERENCES: In-house. PROCEDURE: ...

Jan232023 by KBS.No Comments

Product / Batch Change Over Procedure

Production, SOPs

Product / Batch Change Over Procedure turn around time is the time between the production of the last good part of the current batch and the first good part of the new batch. In other words, this is the time it takes you to physically check the machine and manually record the Product / Batch Change Over Procedure on each machine. Important points are given in identifying this method. Justification, review, review and approval, communication, training, implementation, and Evaluation. Product / Batch Change Over Procedure are an integral part of many manufacturing facilities. However, they also represent a loss of productivity. After all, when you're converting batches, you're not producing the product. This is further enhanced in pharmaceutical manufacturing facilities where Product / Ba...

Jan232023 by KBS.No Comments

General SOP for Batch Processing

Production

Standard Operating Procedure (SOP) for Review of General SOP for Batch Processing in the pharmaceutical manufacturing industry. A detailed checklist for review of General SOP for Batch Processing for Draft Copy as well as Filled Copy of Batch Manufacturing/Packing Records. this SOP is to define the procedure to review the draft General SOP for Batch Processing prior to final approval. Also, this SOP shall be applicable for a review of executed BMR prior to the final release of batches. PURPOSE : To lay down the procedure for manufacturing Tablets and Capsules. SCOPE: This SOP shall be applicable for Tablet & Capsule Manufacturing in the Production department. RESPONSIBILITY: 1 Execution: Production Pharmacist. 2 Checking: Production Manager. 3 Q.A Officer. REFERENCES: In-hous...

Mar12022 by KBS.No Comments

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...

Mar12022 by KBS.No Comments

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...

Mar12022 by KBS.No Comments

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...