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SOP Guide for Pharma

The Ultimate Resource for Pharmaceutical SOPs and Best Practices

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Author: Auditor

SOP for Raw Material Verification Procedure

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1. Purpose The purpose of this standard operating procedure (SOP) is to provide guidelines for the verification of all incoming raw materials before being accepted for use in manufacturing processes. The objective of this procedure is to ensure that only the high-quality raw materials that meet the specifications are used in the manufacturing processes. 2….

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Raw Material Stores

SOP for Raw Material Traceability Procedure

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1. Purpose: The purpose of this Standard Operating Procedure (SOP) is to establish a Raw Material Traceability Procedure that will ensure the identification, tracking and documentation of raw materials used in production. 2. Scope: This SOP applies to all raw material suppliers, production personnel and QA personnel involved in the manufacturing process. 3. Responsibilities: a….

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Raw Material Stores

SOP for Operation of Centrifuge Machine

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Standard Operating Procedure (SOP): Operation of Centrifuge Machine Purpose: The purpose of this Standard Operating Procedure (SOP) is to provide detailed instructions for the safe and efficient operation of a centrifuge machine. This SOP ensures consistent and controlled separation of substances based on their density in a laboratory or testing environment. Scope: This SOP applies…

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Quality Control

SOP for Raw Material Record Keeping

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Purpose: The purpose of this Standard Operating Procedures (SOP) for Raw Material Record Keeping is to outline the procedures for recording and logging of raw materials information. Scope: This SOP applies to all personnel involved in receiving, inspecting, and storing of raw materials. Responsibility: The quality assurance team shall ensure the implementation and maintenance of…

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Raw Material Stores

SOP for Operation of Bacteriological Colony Counter

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Standard Operating Procedure (SOP): Operation of Bacteriological Colony Counter Purpose: The purpose of this Standard Operating Procedure (SOP) is to provide detailed instructions for the safe and accurate operation of a bacteriological colony counter. This SOP ensures consistent and reliable counting of bacterial colonies in a laboratory or testing environment. Scope: This SOP applies to…

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Microbiology Testing, Quality Control

SOP for Raw Material Storage Procedure

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1. Purpose: The purpose of this SOP is to provide standard operating procedures for the storage of raw material. 2. Scope: This SOP is applicable to all raw materials used in the production process. 3. Responsibilities: 3.1. The Quality Assurance (QA) department is responsible for ensuring that the raw materials are stored according to the…

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Raw Material Stores

SOP for Operation of Muffle Furnace

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Standard Operating Procedure (SOP): Operation of Muffle Furnace Purpose: The purpose of this Standard Operating Procedure (SOP) is to provide detailed instructions for the safe and effective operation of a Muffle Furnace. This SOP ensures consistent and accurate heat treatment, ashing, or high-temperature operations on various materials in a controlled environment. Scope: This SOP applies…

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Quality Control

SOP for Operation of Heating Oven

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Standard Operating Procedure (SOP): Operation of Heating Oven Purpose: The purpose of this Standard Operating Procedure (SOP) is to provide detailed instructions for the safe and efficient operation of a Heating Oven. This SOP ensures consistent and controlled heating of materials or samples to specific temperatures in a laboratory or testing environment. Scope: This SOP…

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Quality Control

SOP for Raw Material Receipt Procedure

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Purpose: The purpose of this Standard Operating Procedure (SOP) is to define the procedure for receipt, storage, and documentation of Raw materials at the Pharma Manufacturing facility. Scope: This SOP is applicable to all the Raw materials received at the Pharma Manufacturing facility. Responsibilities: The following personnel shall be responsible for the Raw Material Receipt…

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Raw Material Stores

SOP for Operation of Thin Layer Chromatography

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Standard Operating Procedure (SOP): Operation of Thin Layer Chromatography Purpose: The purpose of this Standard Operating Procedure (SOP) is to provide detailed instructions for the proper operation of Thin Layer Chromatography (TLC). This SOP ensures accurate and reliable separation and analysis of chemical components in a sample. TLC is commonly used in analytical chemistry, pharmaceuticals,…

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Quality Control

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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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