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SOP Guide for Pharma

The Ultimate Resource for Pharmaceutical SOPs and Best Practices

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Author: Auditor

SOP on Raw Material Risk Assessment Procedure

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1.0 Purpose: The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the risk assessment procedure of raw materials used in the production of products to ensure the safety, quality and legality of the final products. 2.0 Scope: This procedure applies to all raw materials used in the production of products at…

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Raw Material Stores

SOP for Regulatory Document Formatting and Templates

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Standard Operating Procedure (SOP) for Regulatory Document Formatting and Templates Purpose: The purpose of this SOP is to establish guidelines and procedures for ensuring consistent formatting, structure, and content of regulatory documents within the organization. This SOP aims to facilitate efficient document creation, review, and submission while adhering to regulatory requirements and maintaining a professional…

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Regulatory Affairs

SOP for Blending Process

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Standard Operating Procedure for Blending Process Purpose: The purpose of this SOP is to provide guidelines for the blending process within the tablet manufacturing department. This SOP aims to ensure the proper blending of raw materials and excipients, adherence to dosage specifications, and compliance with regulatory requirements and Good Manufacturing Practices (GMP). Scope: This SOP applies…

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Tablet Manufacturing

SOP for Operation of Blending Equipment

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Standard Operating Procedure for Operation of Blending Equipment Purpose: The purpose of this SOP is to provide guidelines for the safe and efficient operation of blending equipment within the tablet manufacturing department. This SOP aims to ensure proper blending of raw materials, adherence to dosage specifications, and compliance with regulatory requirements and Good Manufacturing Practices (GMP)….

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Tablet Manufacturing

SOP on Raw Material Handling Record Procedure

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1.0 Purpose: The purpose of this Standard Operating Procedure (SOP) is to describe the process of Raw Material Handling Record Procedure to ensure that all raw materials are handled, tracked, recorded, and stored according to the company’s quality standards and regulations in a consistent and controlled manner. 2.0 Scope: This SOP applies to all employees,…

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Raw Material Stores

SOP on Raw Material Record Keeping Procedure

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1. Purpose: The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for the record keeping of raw materials received in our company. 2. Scope: This SOP shall be applicable to all employees involved in the receipt and storage of raw materials in our company. 3. Responsibilities: 3.1. Warehouse In-charge: The warehouse…

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Raw Material Stores

SOP on Raw Material Traceability Procedure

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1. Purpose: The purpose of this Standard Operating Procedure is to establish a Raw Material Traceability Procedure that ensures traceability of all raw materials used in the manufacturing process. 2. Scope: This SOP applies to all raw materials used in the manufacturing process, including but not limited to raw materials received from suppliers, in-process materials,…

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Raw Material Stores

SOP on Raw Material Verification Procedure

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1.0 Purpose The purpose of this Standard Operating Procedure (SOP) is to provide guidance on the verification of raw materials to ensure that only suitable raw materials are used in manufacturing processes. 2.0 Scope This SOP applies to all employees involved in the receiving and verification of raw materials at the company. 3.0 Responsibility Quality…

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Raw Material Stores

SOP on Raw Material Release Procedure

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Standard Operating Procedure (SOP) for Raw Material Release Procedure 1.0 Purpose: The purpose of this standard operating procedure is to outline the procedure for the release of raw materials at the manufacturing facility. This SOP is intended to ensure the quality and safety of the raw materials used in the production process, as well as…

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Raw Material Stores

SOP on Raw Material Inspection Procedure

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1.0 Purpose: The purpose of this Standard Operating Procedure (SOP) is to establish the procedure for inspecting raw materials before accepting them for use in the manufacturing process. This SOP aims to ensure that all incoming raw materials meet the required quality standards and specifications. 2.0 Scope: This SOP is applicable to all personnel involved…

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Raw Material Stores

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Standard Operating Procedures V 1.0

  • Aerosols
  • Analytical Method Development
  • Bioequivalence Bioavailability Study
  • Capsule Formulation
  • Clinical Studies
  • Creams
  • Data Integrity
  • Dental Dosage Forms
  • Drug Discovery
  • Environment, Health and Safety
  • Formulation Development
  • Gels
  • Good Distribution Practice
  • Good Warehousing Practices
  • In-Process Control
  • Injectables
  • Liquid Orals
  • Liposome and Emulsion Formulations
  • Lotions
  • Lyophilized Products
  • Maintenance Dept.
  • Medical Devices
  • Metered-Dose Inhaler
  • Microbiology Testing
  • Nanoparticle Formulation
  • Nasal Spray Formulations
  • Nebulizers
  • Ocular (Eye) Dosage Forms
  • Ointments
  • Otic (Ear) Dosage Forms
  • Pharmacovigilance
  • Powder & Granules
  • Purchase Departments
  • Quality Assurance
  • Quality Control
  • Raw Material Stores
  • Regulatory Affairs
  • Tablet Manufacturing
  • Rectal Dosage Forms
  • Transdermal Patches
  • Vaginal Dosage Forms
  • Validations and Qualifications

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NEW! Revised SOPs – V 2.0

  • Aerosols V 2.0
  • Analytical Method Development V 2.0
  • API Manufacturing V 2.0
  • BA-BE Studies V 2.0
  • Biosimilars V 2.0
  • Capsules V 2.0
  • Creams V 2.0
  • Elixers V 2.0
  • Ointments V 2.0
  • Raw Material Warehouse V 2.0
  • Tablet Manufacturing V2.0

New Publication: A must for All.

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