General SOPS - Pharma Egg

Jun122024 by KBS.No Comments

Structure & Transport of Material in Production

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

Structure & Transport of Material in Production is the place where the dry products, liquids, capsules, cream are manufactured in their specific area according to standard procedures of GMP. Products shall be manufactured under conditions which minimize deterioration and contamination. Special environmental condition are required for certain products. Introduction These conditions should be continuously monitored and corrective action taken, where necessary. Products are manufactured at temperature 25oC and relative humidity is not more than 50%. Products which are sensitive to humidity are manufactured in special area. Dehumidifier is used for maintaining the humidity less than 50%. Movement of Materials in the Production Area According to monthly plan, on the advice of Producti...

Feb262024 by KBS.1 Comment

Batch Document Review and Inprocess Checks SOP

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

Batch Document Review and Inprocess Checks SOP are essentially a way to ensure quality and consistency during the manufacturing process. Here's a simplified explanation: Batch Document Review: Before making a batch of products, you review all the documents related to the manufacturing process. This includes recipes, instructions, and quality standards to ensure everything is correct and ready to go. In-process Checks: While making the products, you perform regular checks to make sure everything is going according to plan. This could involve measuring ingredients, checking temperatures, or inspecting the product at different stages to catch any issues early on. These steps help maintain quality control and ensure that the final products meet the desired standards. OBJECTIVE ...

Feb262024 by KBS.No Comments

SOP for General Description of Finished Products

Quality Control, General SOPS, General Topics, Product, Quality Assurance, SOPs

SOP for General Description of Finished Products provides a basic overview of the products once they're fully made. It typically includes details like what the product looks like, its size, color, materials used, and any unique features or characteristics. Think of it as a snapshot that helps someone understand what the product is all about without getting into too much technical detail. INTRODUCTION A finished product is any pharmaceutical product that has under gone all stages of production, including packing and labeling. The efficacy and safety of a product can only be assured by analytical monitoring of its quality therefore, the overall purity of a product must therefore, be assessed throughout its manufacturing, storage, distribution and use. The objective can easily be achi...

Jan292024 by KBS.No Comments

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...

Jan62024 by KBS.No Comments

SOP for Conduction of Validation Study

Quality Assurance, General SOPS, SOPs

A Standard Operating Procedure SOP for Conduction of Validation Study is critical in the pharmaceutical industry to ensure that processes, equipment, and systems are validated according to regulatory requirements. This procedure SOP for Conduction of Validation Study is to establish a systematic and documented approach for planning, conducting, and documenting validation studies to ensure that processes, equipment, and systems meet predetermined acceptance criteria and comply with regulatory requirements. Objective: To establish and maintain product integrity, performance and reliability, and to ensure that systems, procedures and equipments are clearly defined, functioning correctly, and are shown to be equipped to achieve the desired results. SOP for Conduction of Validation Stud...

Jan62024 by KBS.No Comments

SOP for Handling of Product Complaints

Quality Assurance, General SOPS, SOPs

A Standard Operating Procedure SOP for Handling of Product Complaints is crucial in the pharmaceutical industry to ensure timely and effective resolution of customer complaints and to meet regulatory requirements. Purpose To describe procedure for handling, investigation and reporting of Product Complaints SOP for Handling of Product Complaints Scope The scope of this document pertains to all type of internal and external complaints of finished products manufactured and marketed by Pacific Pharmaceuticals Ltd Responsibilities It is the responsibility of distribution manager to forward the complaint received from distributor, retailer or customer to QA . In case of internal complaint, Head of Department is responsible to forward the complaint to QA. It is responsibility of Q...

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 Management of Documents

Quality Assurance, General SOPS, SOPs

A Standard Operating Procedure SOP for Management of Documents is crucial in pharmaceutical manufacturing to ensure the control, organization, and traceability of documents. The following is a general outline for creating an SOP for the Management of Documents Purpose To manage all the regulated / GMP documents SOP for Management of Documents Scope The scope of this document pertains to but not limited to all SOPs, forms, records, templates, protocols, reports and related attached documents prepared at Pharmaceuticals Ltd Responsibilities It is the responsibility of QA to prepare, manage and properly implement this SOP. QA ensures that this SOP is followed in its entirety. It is the responsibility of QA Manager or Designee to review this SOP. It is the responsibility o...

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...

Jan62024 by KBS.No Comments

Out of Specifications (OOS) Handling Procedure

Quality Assurance, General SOPS, SOPs

A Standard Operating Procedure (SOP) for Out of Specifications (OOS) Handling Procedure results in the pharmaceutical industry is crucial for managing deviations from established specifications during the testing or manufacturing of pharmaceutical products. Below is a general outline for creating an SOP for handling Out-of-Specification results. Purpose To describe procedure for reporting, investigating and responding out of specification (OOS) analytical results Out of Specifications (OOS) Handling Procedure Scope The scope of this document pertains to the OOS results in QC for Raw materials / Packaging materials, In Process and Finished Products for releasing at Pharmaceuticals Ltd Responsibilities It is the responsibility of all laboratory personnel working in QC to ensure tha...