General Topics - 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...

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.co...

Feb122022 by KBS.No Comments

Ciprofloxacin Hydrochloride Raw Material Testing

General Topics, Quality Control

In this post, we have explained how to perform testing Ciprofloxacin Hydrochloride Raw Material in pharmaceuticals. 1.0 PURPOSE It is established to describe specification and analysis of Ciprofloxacin Hydrochloride, which is one of the components of Tablet. 2.0 SCOPE It is applicable in Material, Product Development and Quality Assurance Department to confirm its physical and chemical specifications. 3.0 REFERENCES USP/BP/inhouse 4.0 DEFINITION Follow SOPs 5.0 SPECIFICATIONS USP/BP/inhouse PHYSICAL ANALYSIS Physical Form Crystalline powder Colour Faintly Yellow to light yellow pH 3.0—4.5 at 25°C ± 2°. Melting point Should be between 318—320°C. Moisture Content Should be between 4.7---6.7 %. Water Contents (by karl Fischer) Between 4.7 to 6.7% CHEMICAL A...

Feb12022 by KBS.No Comments

Insect And Rodent Control SOPs

General Topics, Production

To control insects in pharmaceuticals, this SOP is created Insect And Rodent Control SOPs, Insect and rodents are too much harmful in pharmaceuticals unit. 01 PURPOSE This procedure is established for control of insects and rodents in the plant. 02 SCOPE It is applicable in plant. 03 RESPONSIBILITIES A) It is the responsibility of Production Manager, to ensure that this SOP is followed in its entirety, reviewed and update as necessary. 04 PROCEDURE 4.1 Chemicals required for insect control a) Insecticides b) Fumigants a) Insecticides: Insecticides are classified according to the type of action that results in destruction of the insects. Synthetic organic compound, a single material, produces insecticidal action in several ways. Certain materials are selected and used, howev...

Feb12022 by KBS.No Comments

Entry and Exit for Workers SOPs

General Topics, Production

Entry and Exit for Workers SOPs are created for the a standard Rules to followed by all the worker of pharmaceuticals factory. 1.0 OBJECTIVE 1.1 To describe the procedure for Plant entry/exit through Workers Entrance. 2.0 SCOPE The scope of this SOP pertains to both male and female workers entry or exit in Plant through Workers Entrance. 3.0 RESPONSIBILITIES 3.1 It is the responsibility of all male and female Workers to follow this SOP during Entry or Exit in Plant through Workers Entrance. 3.2 It is the responsibility of Production Manager, to ensure that this SOP is followed in its entirety, reviewed and update as necessary. 4.0 DEFINITIONS & ABBREVIATIONS 4.1 SOP: Standard Operating Procedure 4.2 QC: Quality Control 4.3 QA: Quality Assurance 5.0 MATERIALS & EQUIPME...

Jan282022 by KBS.No Comments

Standard analytical Procedure of Sodium Chloride

General Topics

Standard analytical Procedure of Sodium Chloride Content 99.0 per cent to 100.5 per cent (dried substance). CHARACTERS Appearance White or almost white, crystalline powder or colourless crystals or white or almost white pearls. Solubility Freely soluble in water, practically insoluble in anhydrous ethanol. IDENTIFICATION A. It gives the reactions of chlorides. B. It gives the reactions of sodium. TESTS If the substance is in the form of pearls crush before use. Solution S Dissolve 20.0 g in carbon dioxide-free water R prepared from distilled water R and dilute to 100.0 mL with the same solvent. Appearance of solution Solution S is clear and colourless. Acidity or alkalinity To 20 mL of solution S add 0.1 mL of bromothymol bl...