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Revised SOPs for Ointments V 2.0

Ointments: SOP for Handling Revalidation Requirements – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to define the process for handling revalidation requirements in ointment manufacturing. This ensures continued compliance with Good Manufacturing Practices (GMP), regulatory guidelines, and internal quality standards.
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Ointments V 2.0

Ointments: SOP for Ensuring Validation Compliance – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to define the process for ensuring compliance with validation requirements in ointment manufacturing. This includes adherence to Good Manufacturing Practices (GMP), regulatory guidelines, and internal validation protocols.
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Ointments V 2.0

Ointments: SOP for Validation Protocol Approval – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to define the approval process for validation protocols in ointment manufacturing. This ensures that all validation activities are planned, reviewed, and authorized before execution.
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Ointments V 2.0

Ointments: SOP for Conducting Equipment Validation – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to define the systematic approach for conducting equipment validation in ointment manufacturing. Equipment validation ensures that all machinery and systems used in production meet predetermined specifications and regulatory compliance requirements.
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Ointments V 2.0

Ointments: SOP for Documenting Process Validation Studies – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to define a standardized process for documenting process validation studies in ointment manufacturing. Proper documentation ensures traceability, regulatory compliance, and consistency in product quality.
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Ointments V 2.0

Ointments: SOP for Validation of Batch Size Parameters – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to establish a validated approach for determining and ensuring consistency in batch size parameters in ointment manufacturing. This ensures that variations in batch size do not affect product quality, stability, or compliance with regulatory requirements.
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Ointments V 2.0

Ointments: SOP for Validation of Cleaning Processes – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to define a systematic approach for the validation of cleaning processes in ointment manufacturing. This ensures that cleaning procedures effectively remove residues, prevent cross-contamination, and comply with regulatory requirements.
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Ointments V 2.0

Ointments: SOP for Validation of Filling Processes – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to establish a systematic process for the validation of filling processes in ointment manufacturing. This ensures that the filling operation maintains consistency, accuracy, and compliance with regulatory standards.
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Ointments V 2.0

Ointments: SOP for Validation of Homogenization – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to define the process for validating homogenization in ointment manufacturing. The homogenization process ensures uniform particle size distribution, consistency, and stability of the final product.
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Ointments V 2.0

Ointments: SOP for Validation of Mixing Processes – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to define the systematic approach for the validation of mixing processes used in ointment manufacturing. This ensures that mixing parameters are optimized, reproducible, and meet product quality specifications.
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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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