General Topics - Pharma Egg

Jan312023 by KBS.No Comments

SOP for Process Change Control in Pharmaceuticals

Production, General Topics, Quality Control, SOPs

A formal system by which qualified persons or Subject SOP for Process Change Control in Pharmaceuticals matter Expert of different departments review proposed or actual changes that might affect a validated status of facilities, system, equipment, Document or processes. SCOPE:- This procedure is to be followed while controlling process change in Pharmaceuticals Plant. OBJECTIVE:- To control process variability To operate the process smoothly. RESPONSIBILITY:- Plant Manager Quality Control Manager Quality Assurance Manager Inventory Control Manager Production Manager Maintenance Incharge Critical Process: Following are the critical processes in which change need control in order to control Process variability & for smooth operation: Change of...

Jan312023 by KBS.No Comments

Good Personal Hygiene in Pharmaceuticals

Production, General Topics, Quality Control, SOPs

Good Personal Hygiene in Pharmaceuticals is required in the pharmaceutical industries to protect the product and avoid any contamination that affects the quality of the medicinal product. Good Personal Hygiene in Pharmaceuticals Individuals are responsible for the quality of medicinal products and may therefore be collectively referred to as "staff". Purpose:- The purpose of this procedure is to prevent contamination of Products prepared at the Surge Plant by employees working or Vice Versa. Scope Good Personal Hygiene in Pharmaceuticals:- This procedure is applicable to all the Good Personal Hygiene in Pharmaceuticals working at, .................located HSE Statement:- N.A Responsibility:- Officer QC/QA in coordination with Manager QA/QMR will ensure that SOP has been successfull...

Jan302023 by KBS.No Comments

Washing and Cleaning of Laboratory Glassware

SOPs, General Topics, Quality Control

Washing and Cleaning of Laboratory Glassware isn't as simple as washing the dishes. Here's how to wash your glassware so that you won't ruin your chemical solution or laboratory experiment. For the Washing and Cleaning of Laboratory Glassware detergent and tap water are neither required nor desirable. You can rinse the glassware with the proper solvent, then finish up with a couple of rinses with distilled water, followed by final rinses with deionized water. Purpose:- The procedure is established to ensure the utmost cleanliness of the laboratory glassware for carrying out successful assays and tests without interference from the residues of the previous analysis. It is necessary to ensure the quality of future products handled in the equipment to prevent cross contamination and as a...

Jan302023 by KBS.No Comments

Preparation and Assigning Shelf Life to Reagents & Volumetric Solutions

SOPs, General Topics, Quality Control

Professional quality solutions are possible when high quality and fresh chemicals and solvents are used, and meticulous procedures are followed. Preparation and Assigning Shelf Life to Reagents & Volumetric Solutions of the reagents used in science are in the form of solutions which need to be purchased or prepared. Purpose:- To lay down a procedure for the Preparation and Assigning Shelf Life to Reagents & Volumetric Solutions of shelf life to volumetric solutions and laboratory reagents used for chemical analysis. Scope of Preparation and Assigning Shelf Life to Reagents & Volumetric Solutions:- This SOP is applicable to all laboratory reagents and volumetric solutions used in analytical work for Preparation and Assigning Shelf Life to Reagents & Volumetric Soluti...

Jan292023 by KBS.No Comments

Air Changes and Product Data Analysis

Production, General Topics, SOPs

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...

Jan292023 by KBS.No Comments

Product Processes and Quality of In Process Material

Quality Control, General Topics, SOPs, Testing Methods

The purpose of a Product Processes and Quality of In Process Material system is to provide staff and management with objective insight into the process and related work products. Your process and product quality approach supports the delivery of high-quality products by providing project staff and managers at all levels with appropriate visibility into the process and related work products throughout the life of the pharmaceuticals. Product Processes and Quality of In Process Material Objective:- To ensure compliance of Product Processes and quality of in process material. Responsibility:- Section Supervisor Production Manager QA Incharge Procedure:- Issuance of Raw Material & Packaging Components Check the product name, strength, printing quality and quantity o...

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 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: ...

Feb252022 by KBS.No Comments

How to Test Cloxacillin Sodium

General Topics, Raw Material, Testing Methods

How To Test Cloxacillin Sodium Raw Material specification & analysis prescribes the requirements with IR spectrum and Alternate Method of Analysis on HPLC System and Other Testing procedures. How To Test Cloxacillin Sodium Raw Material PURPOSE This raw material specification & analysis prescribes the requirements for How To Test Cloxacillin Sodium Raw Material which is used in Capsules. PURPOSE This raw material specification & analysis prescribes the requirements for Cloxacillin Sodium (Compacted) which is one of the component of Capsule. SCOPE It is applicable in Material Department, Product Development and Quality Assurance Department to confirm its physical and chemical specifications. REFERENCES USP/BP/Inhouse DEFINITIONS Follow SOP pharmaegg.com SPECI...