Quality Assurance - Pharma Egg

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...

Nov22023 by KBS.No Comments

Cleaning & Disinfection of Plant and Related Offices

General SOPS, General Topics, Production, Quality Assurance, SOPs

Cleaning & Disinfection of Plant and Related Offices facilities and offices is essential to maintain a safe and healthy environment for employees and visitors. Here's a comprehensive guide to help you effectively clean and disinfect your plant and related offices: OBJECTIVES To describe methods of hygiene, cleaning, and disinfection of the plant and related areas. SCOPE The SOP covers the total production, QC/QA laboratories including animal house, stores change / wash rooms and related offices. RESPONSIBILITIES It is the responsibility of the every employ to help maintain the plant and its surrounding areas in the hygienic condition adopting good house keeping practices. Specifically it is direct responsibility of section Incharge to ensure application of cleaning p...

Oct262023 by KBS.No Comments

Equipment Operational Qualification (SOP)

SOPs, Production, Quality Assurance, Quality Control

Equipment Operational Qualification (SOP) is the process, which establishes through verification and documentation that the equipment is capable of operating within established limits and tolerances. This demonstration of basic performance must involve operational aspects of the equipment that will be routinely used in manufacturing. OBECTIVE: This guideline defines the minimum requirements for facility regarding the Equipment Operational Qualification (SOP) which must be performed following Installation Qualification (IQ) and prior to process, system qualification. SCOPE: All critical equipments will require successful completion of Operational Qualification (OQ). For New Equipment: OQ must be completed prior to manufacture of product for process validation. For existing equi...

Oct262023 by KBS.No Comments

Cleaning Validation Standard Operating Procedure

SOPs, Production, Quality Assurance

Equipment changeover Cleaning Validation Standard Operating Procedure must be validated for all major and minor product contact equipment used for multi-product production, subdivision and sampling of drug products and in process materials. INTRODUCTION Validation of cleaning procedures has generated considerable discussion since agency documents, including the Inspection Guide for Bulk Pharmaceutical Chemicals and the Biotechnology Inspection Guide, have briefly addressed this issue. These Agency documents clearly establish the expectation that cleaning procedures (processes) be validated. This guide is designed to establish inspection consistency and uniformity by discussing practices that have been found acceptable (or unacceptable). Simultaneously, one must recognize that for cleani...

Oct252023 by KBS.No Comments

SOP for Purified Water & Potable Water Testing

SOPs, Microbiology, Quality Assurance

Formula: H2O Molecular Weight: 18 Source of Information: WHO/BP/USP Purpose: To avoid microbial contamination in products. Liquid as well as solids. Water Sampling Point Place Tests and Frequency Purpose SP-1 Between Turbine and Tank Chemical and Microbiological: Once in a Month To prove the chemical quality and microbiology of the well water SP-2 Between Tank and Sand Filter Chemical and microbiological. Fortnightly To prove the chemical quality of the well water and the change of the microbial Quality in the Tank SP-3 After Hardness Stabilizing System (Anti-scaling System) Chemical: Twice a week To prove the effect of the Hardness stabilizing system SP-4 Primary storage tank Chemical: Twice a week To prove the efficacy of 1st two memb...

Oct252023 by KBS.No Comments

Standard Operating Procedure for Product Development

Quality Assurance, Production, SOPs

Developing a Standard Operating Procedure for Product Development is crucial for ensuring consistency, quality, and efficiency in the development process. Here's a general outline for creating an SOP for product development. Please tailor this outline to fit the specific needs and processes of your organization and industry: PURPOSE To define and document a procedure for pharmaceutical product development. SCOPE This procedure applies to development of new pharmaceutical product. RESPONSIBILITIES The Managing Director (MD / CEO) approves the initiation of the project. New Product Technical Committee (NPTC) is responsible for designing and documenting inputs and outputs of design and development activities. This committee comprises of: Executive Director (Technical) ...