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

Dec12023 by KBS.No Comments

SOP for Corrective Action in Pharmaceuticals Industry

Quality Assurance, SOPs

SOP for Corrective Action in Pharmaceuticals Industry is crucial for maintaining quality and efficiency in any organization. Here's a general outline that you can customize based on your specific industry or organizational needs. Ensure that the SOP is easily accessible to all relevant personnel and is reviewed periodically to reflect any changes in processes or requirements. Regular training and awareness programs can help ensure that all team members are familiar with the Corrective Action Procedure. Objective: This procedure establishes the process to identify, track, complete the investigation of the problem and correct the causes of existing non-conformances including complaints in products, processes, the Pharmaceuticals Industry Quality Management System, and services in the Pharm...

Nov302023 by KBS.No Comments

SOP for Pharmaceuticals Record and Data Management

Quality Assurance, Production, Quality Control, SOPs

Creating a Standard Operating Procedure SOP for Pharmaceuticals Record and Data Management is essential to ensure compliance with regulatory requirements and maintain the integrity of critical data. Here's a template to help you develop an SOP tailored to pharmaceuticals. Adjust it according to the specific needs and processes of your pharmaceutical organization. Objective: To assure that records used by pharmaceuticals employees are properly managed. Records include reports, correspondence, diaries, quality records and technical records. Quality records include the following: internal audit reports, management reviews, corrective and preventive actions. Technical records include forms, worksheets, control graphs, inspection reports, and test reports. Scope: This procedure applies to t...

Nov302023 by KBS.No Comments

Standard Operating Procedure for Document and Data Control

Production, Quality Assurance, Quality Control, SOPs

Creating a Standard Operating Procedure for Document and Data Control is crucial for ensuring consistency, accuracy, and compliance in managing organizational information. Here's a template you can use as a starting point. Adjust it based on the specific needs and processes of your organization. Objective This procedure ensure that document within the scope of ISO 9001are controlled so that current version of all document is readily available at the point of application. Scope This procedure will apply to all quality environmental, Lab management system document like, all manual, procedure, work instruction standard and specification format etc. Procedure Document Numbering System The numbering scheme of all documents will consist of nine numbers. WW/XX/YY/ZZZ First WW show...

Nov152023 by KBS.No Comments

Sop for Cleaning, Mopping and Fumigation of Sterility Room

Microbiology, General SOPS, SOPs

Certainly! Below is a template for a Standard Operating Procedure SOP for Cleaning, Mopping, and Fumigation of a Sterility Room. This SOP is essential for maintaining a sterile environment in facilities such as pharmaceutical or biotechnology cleanrooms. Ensure that this SOP complies with any applicable regulatory guidelines and industry standards. Additionally, adapt the template to match the specific requirements and processes of your organization. Regularly review and update the SOP to reflect any changes in procedures or equipment. PURPOSE To describe the procedure for cleaning, mopping and fumigation of the sterility test Lab to avoid area / equipment generated Microbial contamination in sterility test Lab. SCOPE This procedure applies to sanitization by disinfecting mopping an...

Nov152023 by KBS.No Comments

Sterility Test Validation Standard Operating Procedure

Microbiology, General SOPS, SOPs

Sterility Test Validation Standard Operating Procedure is a crucial document that outlines the step-by-step process for validating the sterility testing procedures used in a pharmaceutical or biotechnology setting. This SOP ensures that the sterility testing methods are reliable, accurate, and consistent. Here's an outline that you can use to create an SOP for Sterility Test Validation: PURPOSE To assure that sterility test with direct inoculation will produce the same results when tested as per Sterility Test Validation Standard Operating Procedure. State the purpose of the SOP, which is to establish a standardized procedure for the validation of sterility testing methods. SCOPE This Sterility Test Validation Standard Operating Procedure is applicable for sterility of products. Define...

Nov82023 by KBS.No Comments

SOP for Personnel Qualification of Aseptic Area and Sterility Testing Area

Microbiology, General SOPS, SOPs

PURPOSE To lay down a qualification SOP for Personnel Qualification of Aseptic Area and Sterility Testing Area. The role of manufacturing department and quality control departments is to perform environmental monitoring. SCOPE This SOP for Personnel Qualification of Aseptic Area and Sterility Testing Area is applicable to Sterility testing area of microbiology lab and sterile injectable facility. The scope for aseptic processing is suitable for sterility testing field of sterile injectable capacity and microbiology laboratory. The SOP is mainly applied for the qualified individuals only for controlling the entry, exit and aseptic area gowning. RESPONSIBILITIES Microbiologist and all personnel are responsible to full fill the qualification requirements while entering sterile area.&...

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 pharmaceu...