KBS. - Pharma Egg - Page 5 of 25

Dec92023 by KBS.No Comments

Acetic Acid Glacial Testing Procedure (SAP)

Raw Material, Quality Control, Testing Methods

The term "SAP" in the context of acetic acid glacial testing likely refers to the "Saponification Value" or "Saponification Acid Value." The Acetic Acid Glacial Testing Procedure (SAP) saponification value is a measure of the average molecular weight of all the fatty acids present in a substance. It is often used in the analysis of fats and oils. Here's a general procedure for determining the saponification value of acetic acid glacial: PURPOSE To ensure the quality of incoming Raw Material. SCOPE It is applicable to the Quality Control Department. RESPONSIBILITY Quality Control Manager Asst. Quality Control Manager Analyst Lab Assistant PROCEDURE Machinery/Equipment/Apparatus Analytical balance Glass Wares Silica crucible Hot plate Desiccator B...

Dec92023 by KBS.No Comments

SOP for Operation of Autoclave Use in Pharmaceutical Industry

Instrument SOP, Microbiology, SOPs

A Standard Operating Procedure SOP for Operation of Autoclave Use in Pharmaceutical Industry is crucial to ensure the proper sterilization of equipment, materials, and products. Here's an example SOP outline for the operation of an autoclave. This example SOP serves as a general guideline. Adjustments should be made to align with the specific equipment and procedures within your pharmaceutical facility. Regular review and updates to SOPs are necessary to ensure compliance with current industry standards and regulations. PURPOSE To lay down a procedure for the operation of steam sterilizer (Autoclave). The objective of this SOP is to outline the proper procedures for the safe and effective operation of the autoclave to achieve sterilization of equipment, materials, and products in comp...

Dec12023 by KBS.No Comments

General Instructions for Instruments in Pharmaceuticals (SOP)

Instrument SOP, General Topics, Quality Assurance, SOPs

General Instructions for Instruments in Pharmaceuticals (SOP) emphasizing the importance of proper instrument handling and usage to ensure accuracy, reliability, and safety. INTRODUCTION Identification and analysis of different product are made by different technique either by physical or chemical method, involving a specified machinery called Instrument are used at different stages of the product up to finished form. INSTRUMENTAL METHOD The method dependent upon measurement of an electrical property and those based upon determination of the extent to which radiation is absorbed or upon assessment of intensity of emitted radiation, all require the use of suitable instrument e.g. Polarimeter, Spectrophotometer etc. and in consequence such method are referred to as INSTRUMENTAL METHOD. E...

Dec12023 by KBS.No Comments

SOP for Installation Qualification Protocol and Formats

Instrument SOP, General Topics, Production, Quality Assurance, Quality Control

SOP for Installation Qualification Protocol and Formats is a critical phase in the validation process for equipment, systems, and utilities in regulated industries like pharmaceuticals, biotechnology, and medical devices. An IQ protocol is a document that outlines the procedures and criteria for the installation and verification of equipment. Below is an outline of an Installation Qualification Protocol along with suggested formats for key sections: INTRODUCTION Installation Qualification (IQ) is the process, which establishes through verification and documentation that the <Name of equipment> exists and is installed according to specification. Verification of appropriate documentation, such as, SOPs, drawings, repair parts lists, calibration methods, etc. for each piece of filter ...

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.&...