SOPs

Standard Operating Procedures (SOPs) provides end-users with clear instructions on how to work and develop enough to ensure that all end-users can perform their tasks in a consistent and consistent manner. Many processes can be difficult, and it is important to have a balance between too few and too many points. If there are too few points, the end-user will follow their path. On the other hand, too much information and too much detail increase the risk that the end-user will struggle to understand and perform everyday steps, resulting in errors and omissions.

Sops are of different types like Quality Control SOPs, General SOPs, Production SOps, R&D, Regulatory and Validation SOPs etc

Nov82023 by KBS.No Comments

SOP for BET Validation by Gel Clot Method

Microbiology, General SOPS, General Topics, SOPs

Pharmaegg.com, I am writing this Statement of Purpose to outline the purpose and procedures involved in the validation of endotoxin testing using the Gel Clot Method as per the requirements of the United States Pharmacopeia (USP) and other relevant regulatory guidelines. I am committed to ensuring the accuracy, reliability, and reproducibility of endotoxin testing in our laboratory setting. Through this SOP, I aim to establish clear guidelines and protocols for the validation of the Gel Clot Method, a widely accepted technique for bacterial endotoxin testing (BET). PURPOSE This SOP for BET Validation by Gel Clot Method has been established to provide the guidelines for the validation of Gel Clot Method in Microbiological lab to ensure the quality and purity of lysate. This provides a ...

Nov72023 by KBS.No Comments

SOP for Preservative Efficacy Test

Microbiology, General SOPS, SOPs

A Standard Operating Procedure (SOP) for a Preservative Efficacy Test outlines the step-by-step process for conducting tests to determine the effectiveness of preservatives in cosmetic, pharmaceutical, and other products. This test is crucial to ensure that products remain safe and free from microbial contamination throughout their shelf life. Here's a sample SOP for a Preservative Efficacy Test: PURPOSE To provide guidelines for preservative efficacy test and determine the effectiveness of preservatives in products by assessing their ability to inhibit the growth of microorganisms. SCOPE This SOP for Preservative Efficacy Test is applicable for preservatives used for aseptic filling to inhibit the growth of microorganisms in product. This SOP applies to all personnel involved in condu...

Nov32023 by KBS.No Comments

Amlodipine Besylate and Olmesartan Medoxomil Tablet Testing Method

Testing Methods, Product, SOPs

There are different methods available for Amlodipine Besylate and Olmesartan Medoxomil Tablet Testing Method, but here is a general overview of some common analytical methods: HPLC Method: High-Performance Liquid Chromatography (HPLC) is a widely used analytical method for the quantification of Amlodipine Besylate and Olmesartan Medoxomil in tablets. In this method, a liquid sample is passed through a column packed with stationary phase materials, and the components are separated based on their chemical and physical properties. The separated components are detected using a UV detector, and the amount of each component is calculated. Spectroscopic Method: UV-Visible spectrophotometry is a simple and cost-effective method for the quantitative analysis of Amlodipine Besylate and Olmesar...

Nov32023 by KBS.No Comments

Good Manufacturing Practice (GMP)

SOPs, General SOPS, General Topics

Good manufacturing practices are the units of the principles, regulations, codes (law or professional standard), recommendations and tactics, and section of nice assurance gadgets which have to be observed with the aid of the producers to make sure that the merchandise that is constantly produced are of best well known and terrific for their meant use and cowl the manufacturing and checking out of pharmaceutical dosage shape and lively pharmaceutical ingredients, diagnostics, foods, a range of different pharmaceutical merchandise and clinical units. GMP Principles: Good manufacturing exercise tips afford preparation for manufacturing, testing, and fine assurance in order to make certain that drug product is secure for human consumption. Many nations have legislated that pharmaceutical ...

Nov32023 by KBS.No Comments

Standard Operating Procedure (SOP) for Growth Promotion Test

Microbiology, SOPs

This SOP provides a United States Pharmacopoeia guideline for conducting a Growth Promotion Test. Always refer to specific pharmacopeial references and laboratory quality management system guidelines when performing the test for microbiological media used in specific applications. This Standard Operating Procedure (SOP) outlines the steps for conducting a Growth Promotion Test (GPT) to ensure the quality and performance of microbiological media used in the laboratory. Standard Operating Procedure (SOP) for Growth Promotion Test PURPOSE To describe the procedure for the growth promotion test of Medias used in Microbiology Lab for routine testing. SCOPE Procedure is applied to incoming Medias for microbiological tests. RESPONSIBILITIES AND AUTHOROTIES Manager Quality Control is r...

Nov32023 by KBS.No Comments

Standard Operating Procedure (SOP) for Preparation of Peptone Water

Microbiology, SOPs

This Standard Operating Procedure (SOP) outlines the steps for the preparation of Peptone Water, a common microbiological medium used for the cultivation and maintenance of a wide range of microorganisms. Standard Operating Procedure (SOP) for Preparation of Peptone Water PURPOSE This procedure has been established to provide the guidelines for preparation of Peptone Water. SCOPE This procedure is applicable to microbiological section of Quality Control Lab. RESPONSIBILITIES’ & AUTHORITIES Microbiologist is responsible for proper preparation of this culture media. Quality Control Manager is responsible for implementation of this SOP. REFERENCES & REQUIREMENTS Manufacturers COA USP general chapters DEFINITIONS & ABBREVIATIONS Dehydrated culture media: It is a mast...

Nov32023 by KBS.No Comments

SOP for Preparation of Fluid Thioglycollate Medium (FTM)

Microbiology, SOPs

This Standard Operating Procedure (SOP) outlines the steps for the preparation of Fluid Thioglycollate Medium (FTM), a versatile enrichment medium used in microbiological laboratories for the cultivation and maintenance of anaerobic and microaerophilic bacteria. SOP for Preparation of Fluid Thioglycollate Medium (FTM) PURPOSE This procedure has been established to provide the guidelines for preparation of Fluid Thioglycolate Medium. SCOPE This procedure is applicable to microbiological section of Quality Control Lab. RESPONSIBILITIES’ & AUTHORITIES Microbiologist is responsible for proper preparation of this culture media. Quality Control Manager is responsible for implementation of this SOP. REFERENCES & REQUIREMENTS Manufacturers COA USP general chapter...

Nov32023 by KBS.No Comments

Standard Operating Procedure for Preparation of Tryptic Soya Broth

Microbiology, SOPs

This Standard Operating Procedure for Preparation of Tryptic Soya Broth outlines the steps for the preparation of Tryptic Soya Broth, a commonly used medium in microbiology for the cultivation of a wide variety of microorganisms. PURPOSE This Standard Operating Procedure for Preparation of Tryptic Soya Broth has been established to provide the guidelines for preparation of Tryptic Soy Broth. SCOPE This procedure is applicable to microbiological section of Quality Control Lab. RESPONSIBILITIES & AUTHORITIES Microbiologist is responsible for proper preparation of Standard Operating Procedure for Preparation of Tryptic Soya Broth culture media. Quality Control Manager is responsible for implementation of this Standard Operating Procedure for Preparation of Tryptic Soya Broth ...

Nov22023 by KBS.No Comments

Guidelines for Equipment Installation Qualification (SOP)

Quality Control, General SOPS, SOPs

The purpose of this procedure is to outline the Guidelines for Equipment Installation Qualification (SOP) requirements and acceptance criteria for the critical equipment serving to Pharmaceutical Limited facility. This Standard Operating Procedure outlines the guidelines for Equipment Installation Qualification (IQ) at pharmaegg.com. Guidelines for Equipment Installation Qualification (SOP) is a critical step in ensuring that newly acquired equipment is properly installed, calibrated, and ready for use. Adhering to these guidelines guarantees the integrity, accuracy, and reliability of the equipment, contributing significantly to the quality and consistency of our research and development efforts. OBECTIVE: Guidelines for Equipment Installation Qualification (SOP) location and purpose of...

Nov22023 by KBS.No Comments

Reverse Osmosis Water System (SOP)

General SOPS, General Topics, Quality Control, SOPs

1.0 RAW WATER Reverse Osmosis Water System (SOP) is that water, which is obtained from well or any reservoir. Reverse Osmosis Water System (SOP) contains minerals, salts chlorides, sulfates, calcium & magnesium etc. Microbial count of raw water, which may be used for drinking, is 500CFU/ml. The ingredients present in this water may be incompatible with our medicine and can disturb the stability of product so, purification of this water is required. 2.0 PURIFIED WATER Purified water is that water which is obtained by distillation, ion exchange treatment, reverse osmosis or other suitable process from suitable potable water. It contains no added substances Purified water is required for manufacturing of quality medicine in Searle P...