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Revised SOPs for Ointments V 2.0

Ointments: SOP for Archiving Ointment Manufacturing Records – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to establish a systematic method for archiving ointment manufacturing records. Proper archiving ensures compliance with Good Manufacturing Practices (GMP), facilitates audits, and maintains traceability of batch production records, test reports, and regulatory documents.
Click to read the full article.

Ointments V 2.0

Ointments: SOP for Ensuring Data Integrity in Documentation – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to establish a systematic approach for ensuring data integrity in pharmaceutical documentation. Data integrity is essential for maintaining compliance with Good Manufacturing Practices (GMP), regulatory requirements, and audit readiness.
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Ointments V 2.0

Ointments: SOP for Maintaining QA Approval Logs – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to establish a systematic approach for maintaining Quality Assurance (QA) approval logs in pharmaceutical manufacturing. These logs provide traceability and ensure regulatory compliance for batch approvals, document verifications, deviation authorizations, and other QA-related activities.
Click to read the full article.

Ointments V 2.0

Ointments: SOP for Filing Validation Protocols – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to establish a systematic method for filing validation protocols in pharmaceutical manufacturing. Proper documentation of validation protocols ensures compliance with Good Manufacturing Practices (GMP), regulatory requirements, and traceability for audits and inspections.
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Ointments V 2.0

Ointments: SOP for Preparing Stability Study Reports – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to establish a systematic approach for preparing Stability Study Reports in pharmaceutical manufacturing. Stability studies evaluate the effect of environmental factors such as temperature, humidity, and light on drug products to determine their shelf life and storage conditions.
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Ointments V 2.0

Ointments: SOP for Recording Deviations and CAPA Reports – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to define the systematic approach for identifying, documenting, investigating, and addressing deviations in pharmaceutical manufacturing. It also outlines the Corrective and Preventive Action (CAPA) process to ensure continual improvement and compliance with Good Manufacturing Practices (GMP).
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Ointments V 2.0

Ointments: SOP for Filing Raw Material Inspection Reports – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to establish a systematic method for filing raw material inspection reports in pharmaceutical manufacturing. Proper documentation of raw material inspections ensures compliance with Good Manufacturing Practices (GMP), regulatory requirements, and traceability.
Click to read the full article.

Ointments V 2.0

Ointments: SOP for Preparing Cleaning Records – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to establish a systematic method for preparing cleaning records in pharmaceutical manufacturing. Cleaning records ensure proper documentation of cleaning procedures performed on equipment, production areas, and storage areas, which is essential for regulatory compliance, product quality, and cross-contamination prevention.
Click to read the full article.

Ointments V 2.0

Ointments: SOP for Maintaining Equipment Logbooks – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to establish a systematic process for maintaining equipment logbooks in pharmaceutical manufacturing. Equipment logbooks ensure proper documentation of equipment usage, cleaning, maintenance, and calibration, which is critical for regulatory compliance, traceability, and adherence to Good Manufacturing Practices (GMP).
Click to read the full article.

Ointments V 2.0

Ointments: SOP for Preparing Batch Manufacturing Records – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to define a systematic approach for preparing Batch Manufacturing Records (BMR) in pharmaceutical manufacturing. Proper documentation ensures compliance with Good Manufacturing Practices (GMP), facilitates traceability, and maintains consistency in manufacturing processes.
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Ointments 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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