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Production

Manufacturing Facility in Pharmaceuticals Industry have different type & Section that we explain here

GMP Questionnaire for Excipients

GMP Questionnaire for Excipients

Raw Material, General SOPS, General Topics, Microbiology, Product, Production, Quality Assurance, Quality Control, SOPs, Testing Methods
A Good Manufacturing Practice GMP Questionnaire for Excipients is a tool used to assess and qualify excipient suppliers to ensure compliance with regulatory standards and quality requirements. Part I: To be Completed by Supplier A) Contact Details Name: Address: Postal Code, City: Country: Telephone / fax / E-mail: Contact Person: Is your company the subsidiary of another company or corporation? Yes No If yes, please state name of parent company: Number of local employees: What services do you offer? (enclose a description, if applicable) Is your company certified according to MP (if yes, please enclose certificate) Yes No Part II: To be Completed by Manufacturer Only I confir...
Laboratory Equipment Qualification Procedure SOP

Laboratory Equipment Qualification Procedure SOP

Quality Assurance, Production, Quality Control, SOPs
Laboratory Equipment Qualification Procedure SOP outlines the steps and processes for qualifying laboratory equipment to ensure its reliability, accuracy, and compliance with regulatory requirements. Below is a general template for such a procedure. Please note that specific details may need to be tailored based on the type of equipment and regulatory requirements applicable to your laboratory. PURPOSE To describe the procedure for defining the responsibilities, planning, protocol writing, performing the qualification activity, and subsequent record generation. The purpose of this Standard Operating Procedure (SOP) is to establish a systematic approach for the qualification of laboratory equipment to ensure accurate and reliable results and compliance with regulatory requirements. SCO...
SOP for Managing the Product Recall Process

SOP for Managing the Product Recall Process

Quality Assurance, General Topics, Production, SOPs
SOP for Managing the Product Recall Process is crucial for organizations to manage and execute an efficient and effective recall process when necessary. This SOP should provide clear guidelines on how to identify, initiate, and execute a product recall to minimize risks to consumers and comply with regulatory requirements. OBJECTIVE The purpose of this Work Instruction is to describe the procedure for the management of the recall, or potential recall, of sales products from the marketplace. Clearly state the purpose of the SOP, which is to establish a systematic process for managing product recalls to ensure the safety of consumers, comply with regulatory requirements, and protect the reputation of the organization. SCOPE This Work Instruction applies to all products manufactured and m...
SOP for Manufacturing In process Control

SOP for Manufacturing In process Control

Quality Assurance, General Topics, Production, SOPs
SOP for Manufacturing In process Control for Manufacturing In-Process Control is essential to ensure the quality and consistency of products during the manufacturing process. These procedures help monitor and control critical parameters at various stages of production. Purpose To describe procedures for manufacturing in process control. Clearly state the purpose of the SOP, which is to establish guidelines and procedures for the implementation of in-process controls to monitor and maintain the quality of products during manufacturing. Scope This SOP applies to all in process manufacturing control. Define the scope of the SOP, specifying the manufacturing processes and stages where in-process controls are applicable. Responsibilities It is the responsibility of QAIP and Assistant ...
Standard operating procedure for Equipment Qualification

Standard operating procedure for Equipment Qualification

Quality Assurance, General Topics, Production, Quality Control, SOPs
Standard operating procedure for Equipment Qualification is a critical process in various industries, including pharmaceuticals, biotechnology, healthcare, and manufacturing. It ensures that equipment meets specified requirements and is suitable for its intended purpose. Standard Operating Procedures (SOPs) for equipment qualification help maintain consistency, reliability, and compliance with regulatory standards. Objective: Objective of this SOP is to address the guidelines for the execution of the Equipment Qualification i.e. (Installation Qualification (IQ)), (Operational Qualification (OQ)) and (Performance Qualification (PQ)). Clearly state the purpose of the SOP, which is to define the systematic process for qualifying equipment to ensure its reliability, accuracy, and compliance ...
Determining Shelf Life And Stability Testing Programme

Determining Shelf Life And Stability Testing Programme

Quality Assurance, General Topics, Product, Production, Quality Control, SOPs
Standard Operating Procedure for Determining Shelf Life And Stability Testing Programme Determining Shelf Life And Stability Testing Programme is the stability testing programmed for all pharmaceutical products manufactured at Company facility confirm the stability of the products and compatibility. PURPOSE To describe the stability testing programmed for all pharmaceutical products manufactured at Company facility. To confirm the stability of the products and compatibility with its container, while stored in accordance with labeling conditions and time, and with respect to product degradation. Pharmaceutical products will be tested at designated intervals for certain physical, chemical and microbiological properties. To collect scientific evidence based on test results to d...
SOP for Qualification of Service Provider

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...
SOP for cGMP Internal Audit / Self Inspection

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...
Classification of HVAC Systems in Pharmaceuticals

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...
SOP for Installation Qualification Protocol and Formats

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 ...