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SOP Guide for Pharma

The Ultimate Resource for Pharmaceutical SOPs and Best Practices

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SOPs for Raw Material Stores

This is a comprehensive list of Standard Operating Procedures (SOPs) specifically designed for raw materials in the pharmaceutical industry. As a leading authority in the field, we recognize the critical role that raw materials play in ensuring the safety, efficacy, and quality of pharmaceutical products. This meticulously curated collection of SOPs serves as a valuable resource for professionals involved in raw material management, quality control, and manufacturing processes within the pharmaceutical sector. Each SOP has been carefully developed to meet international regulatory standards and address the unique challenges associated with raw material sourcing, testing, handling, and documentation.

Here is a list of  SOPs related to Raw Materials:

SOP for Raw Material Inspection Procedure

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1. Purpose: The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the raw material inspection procedure and to provide assurance that all raw materials used in the manufacturing process meet the specifications for quality, safety, and effectiveness. 2. Scope: This procedure applies to all raw materials received by the manufacturing facility,…

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Raw Material Stores

SOP for Raw Material Investigation

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SOP for Raw Material Investigation Procedure Purpose: The purpose of the Raw Material Investigation Procedure is to ensure that all incoming raw materials meet the required specifications, minimize the risk of contamination, and prevent the usage of non-conforming raw materials in manufacturing. Scope: This SOP applies to all raw materials that are acquired for the…

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Raw Material Stores

SOP for Raw Material Non-conformance Procedure

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Purpose: The purpose of this SOP is to define the procedure for dealing with raw material non-conformance in a consistent and efficient manner. The non-conformance should be identified and handled in a way that minimizes the impact on final product quality and customer satisfaction. Scope: This SOP applies to all raw materials used in the…

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Raw Material Stores

SOP for Raw Material Change Request Procedure

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Title: Raw Material Change Request Procedure Purpose: The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for requesting and evaluating raw material changes in compliance with regulatory requirements and company quality standards. Scope: This SOP applies to all personnel involved in raw material change requests, approval, evaluation, and implementation at [Company…

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Raw Material Stores

SOP for Raw Material Complaint Handling Procedure

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Purpose: The purpose of this Standard Operating Procedure (SOP) is to establish a standard and consistent procedure for handling raw material complaints. The objective of this procedure is to ensure that all complaints made related to raw materials are investigated thoroughly, documented accurately, and resolved adequately to prevent future occurrences. Scope: This SOP applies to…

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Raw Material Stores

SOP for Raw Material Certificate of Analysis Review Procedure

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Purpose: The purpose of this procedure is to define the process for reviewing Raw Material Certificates of Analysis (COA) to ensure that the raw materials received meets the required specifications and comply with regulatory requirements. Scope: This procedure applies to all raw materials received by the company. Responsibilities: The Quality Control (QC) team is responsible…

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Raw Material Stores

SOP for Raw Material Rejection Procedure

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SOP: Raw Material Rejection Procedure 1. Purpose: The purpose of this SOP is to define the procedure for the rejection of raw materials that do not meet the required quality standards. This is to ensure that only high-quality materials are used in the manufacturing of products, thereby meeting customer requirements and improving product quality. 2….

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Raw Material Stores

SOP for Raw Material Expiry Date Management Procedure

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1. Purpose: The purpose of this SOP is to establish a procedure for the effective management of raw material expiry date to ensure that materials are used within their shelf life. 2. Scope: This procedure applies to all raw materials used in the production processes at the company. 3. Responsibilities: a. Procurement Department: Responsible for…

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Raw Material Stores

SOP for Raw Material CoA Retention Procedure

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SOP for Raw Material CoA Retention Procedure Purpose: To establish a standard procedure for the retention of raw material Certificate of Analysis (CoA) that ensures that the CoA is available when needed and can be retrieved easily. Scope: This SOP applies to the retention of raw material Certificate of Analysis for all raw materials used…

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Raw Material Stores

Raw Material Sampling Plan: Procedure for Water Sampling

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The Raw Material Sampling Plan Procedure for Water outlined in this SOP is critical to ensuring the quality and safety of the water used in the manufacturing processes. By following this procedure, the company can ensure that all water used in the manufacturing processes meets the specified quality standards and does not pose any health…

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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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