Production - Pharma Egg

Jan62024 by KBS.No Comments

SOP for Qualification of Service Provider

Quality Assurance, General SOPS, Production, SOPs

A Standard Operating Procedure SOP for Qualification of Service Provider is essential in the pharmaceutical industry to ensure that external entities providing services meet the necessary quality and regulatory requirements. This SOP for Qualification of Service Provider is to establish a systematic and documented approach for the qualification, selection, and ongoing assessment of external service providers to ensure that they meet the quality and regulatory requirements of the pharmaceutical organization. Purpose To describe procedure for qualification of service provider. SOP for Qualification of Service Provider Scope The scope of this document pertains to qualification of service provider of Pharmaceuticals Ltd Responsibilities It is the responsibility of Procurement de...

Jan62024 by KBS.No Comments

SOP for cGMP Internal Audit / Self Inspection

Quality Assurance, General SOPS, Production, Quality Control, SOPs

A Standard Operating Procedure SOP for cGMP Internal Audit / Self Inspection in the pharmaceutical industry is vital for ensuring compliance with Good Manufacturing Practice (cGMP) guidelines and maintaining a high level of quality and safety in the manufacturing process. Below is a general outline for creating an SOP for cGMP Internal Audit or Self-Inspection Purpose To describe procedure for planning, executing, reporting and follow up of cGMP internal audit as well as Self Inspection SOP for cGMP Internal Audit / Self Inspection Scope The scope of this document pertains to all regulated departments including, Production, Quality Control, Quality Assurance, Procurement, Engineering, Warehouses and IT department of Pacific Pharmaceuticals Ltd Responsibilities QA Head is respon...

Jan32024 by XhaamiNo Comments

Classification of HVAC Systems in Pharmaceuticals

Instrument SOP, Microbiology, Production, SOPs

In the pharmaceutical industry, the proper control of temperature and air quality is essential for ensuring the quality, safety, and efficacy of products. Classification of HVAC Systems in Pharmaceuticals (heating, ventilation, and air conditioning) systems play a crucial role in maintaining the required conditions for pharmaceutical manufacturing, storage, and distribution. The HVAC system helps to maintain cleanroom conditions, regulate temperature and humidity levels, and provide fresh and filtered air. Pharmaceutical facilities often require a high level of control over environmental conditions to meet regulatory requirements, prevent contamination, and ensure product stability. The Classification of HVAC Systems in Pharmaceuticals is a critical component of the overall environmenta...

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 ...

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

Insects and Rodents Control in Pharmaceutical Industry

General SOPS, Production, SOPs

Controlling insects and rodents in the pharmaceutical industry is crucial to maintaining a safe and sanitary environment. Insects and Rodents Control in Pharmaceutical Industry infestations can contaminate products, compromise the integrity of the manufacturing process, and pose serious health risks. Here are some guidelines to help control insects and rodents in a pharmaceutical facility INTRODUCTION: In Pharmaceutical insects may be controlled through proper applications of chemicals and by some specialized devices. 1. Chemicals Insecticides Fumigants Repellants Attractants 2. DEVICES: Mechanical. a. Insecticides: Insecticides are after classified according to the type of action that results in destruction of the insects. Synthetic organie compounds a si...

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...