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SOP Guide for Pharma

The Ultimate Resource for Pharmaceutical SOPs and Best Practices

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SOPs for Capsules V 2.0

Capsule: SOP for Cleaning Stainless Steel Surfaces in Capsule Areas – V 2.0

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The purpose of this SOP is to outline the procedure for cleaning stainless steel surfaces in capsule manufacturing areas. Regular cleaning of stainless steel surfaces ensures that they remain free of contaminants and residues, which is essential for maintaining product quality and compliance with GMP (Good Manufacturing Practices).

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Capsules V 2.0

Capsule: SOP for Ensuring Traceability in Capsule Manufacturing Documentation – V 2.0

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The purpose of this SOP is to ensure proper traceability of capsule manufacturing documentation. Traceability ensures that all manufacturing steps, materials, equipment, and personnel actions are documented, allowing for the complete tracking of a batch from production to final distribution.

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Capsules V 2.0

Capsule: SOP for Maintaining Training Records for Capsule Operators – V 2.0

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The purpose of this SOP is to outline the procedure for maintaining training records for capsule operators. Proper documentation of training activities ensures compliance with GMP, regulatory standards, and the ongoing competence of operators in capsule manufacturing processes.

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Capsules V 2.0

Capsule: SOP for Documenting QC Test Results for Capsules – V 2.0

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The purpose of this SOP is to establish the procedure for documenting the results of Quality Control (QC) tests performed on capsules. Proper documentation ensures the integrity, traceability, and compliance of test results with regulatory and GMP requirements.

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Capsules V 2.0

Capsule: SOP for Recordkeeping for Stability Studies of Capsules – V 2.0

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The purpose of this SOP is to establish a procedure for recordkeeping of stability studies conducted on capsules. Accurate and detailed recordkeeping ensures that all stability testing data is preserved for regulatory compliance, traceability, and future use.

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Capsules V 2.0

Capsule: SOP for Documentation of Process Deviations in Capsule Production – V 2.0

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The purpose of this SOP is to outline the process for documenting and managing process deviations in capsule production. Ensuring that all deviations are identified, documented, and reviewed helps maintain product quality, safety, and compliance with GMP and regulatory requirements.

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Capsules V 2.0

Capsule: SOP for Maintaining Cleaning Logs for Capsule Equipment – V 2.0

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The purpose of this SOP is to define the procedure for maintaining cleaning logs for capsule manufacturing equipment. The cleaning logs ensure that all equipment used in the production of capsules is thoroughly cleaned, documented, and compliant with Good Manufacturing Practices (GMP).

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Capsules V 2.0

Capsule: SOP for Preparing Batch Packing Records for Capsules – V 2.0

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The purpose of this SOP is to define the procedure for preparing Batch Packing Records (BPRs) for capsules. The BPR ensures that all packaging steps, materials, and processes are documented and compliant with GMP and regulatory requirements.

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Capsules V 2.0

Capsule: SOP for Archiving Capsule Manufacturing Records – V 2.0

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The purpose of this SOP is to establish a procedure for the proper archiving of capsule manufacturing records to ensure that all records are stored, maintained, and readily accessible for future reference, audits, and regulatory inspections.

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Capsules V 2.0

Capsule: SOP for Reviewing Batch Manufacturing Records (BMRs) – V 2.0

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The purpose of this SOP is to define the procedure for reviewing Batch Manufacturing Records (BMRs) for capsules. This ensures that all manufacturing processes have been conducted in compliance with Good Manufacturing Practices (GMP) and regulatory requirements.

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Capsules V 2.0

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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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