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SOP Guide for Pharma

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Revised SOPs for Ointments V 2.0

Ointments: SOP for Creating Prototype Ointment Samples for Clinical Studies – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to define a systematic approach for creating prototype ointment samples intended for clinical studies. This process ensures that the formulation meets safety, efficacy, and regulatory requirements before large-scale production.
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Ointments V 2.0

Ointments: SOP for Scaling Up Formulations from Lab to Pilot Scale – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to establish a systematic approach for scaling up pharmaceutical ointment formulations from laboratory-scale development to pilot-scale production. This process ensures consistency, reproducibility, and compliance with regulatory guidelines while optimizing manufacturing parameters.
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Ointments V 2.0

Ointments: SOP for Formulation Optimization Using Design of Experiments (DoE) – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to define a systematic approach for optimizing pharmaceutical ointment formulations using Design of Experiments (DoE). The goal is to achieve robust and high-quality formulations by statistically analyzing the impact of different formulation parameters.
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Ointments V 2.0

Ointments: SOP for Developing Ointments for Specific Skin Conditions – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to define a systematic approach for developing ointments targeted at specific skin conditions such as eczema, psoriasis, dermatitis, fungal infections, acne, and burns. This ensures product efficacy, stability, patient safety, and compliance with regulatory standards.
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Ointments V 2.0

Ointments: SOP for Evaluating Bioavailability of Active Ingredients in Ointments – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to define a systematic approach for evaluating the bioavailability of active pharmaceutical ingredients (APIs) in ointments. This ensures therapeutic efficacy, product consistency, and regulatory compliance.
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Ointments V 2.0

Ointments: SOP for Conducting Risk Assessments in Ointment Development – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to establish a structured approach for conducting risk assessments in ointment development. This ensures product safety, efficacy, regulatory compliance, and quality consistency by identifying, evaluating, and mitigating potential risks associated with formulation, manufacturing, and stability.
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Ointments V 2.0

Ointments: SOP for Incorporating Excipients in Ointment Formulations – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to establish a systematic approach for selecting, handling, and incorporating excipients in ointment formulations to ensure product stability, efficacy, and compliance with regulatory standards.
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Ointments V 2.0

Ointments: SOP for Evaluating Sensory Attributes of Ointments – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to define a systematic approach for evaluating the sensory attributes of pharmaceutical ointments. Sensory evaluation is crucial for ensuring patient acceptability, product consistency, and compliance with regulatory guidelines.
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Ointments V 2.0

Ointments: SOP for Conducting Accelerated Stability Testing During Development – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to define a systematic approach for conducting accelerated stability testing during the development phase of pharmaceutical ointments. This ensures that the formulation maintains its intended quality, safety, and efficacy under stress conditions, in compliance with regulatory guidelines.
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Ointments V 2.0

Ointments: SOP for Developing Ointments with Sustained Release Properties – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to define a systematic approach for developing ointments with sustained release properties. This ensures consistent drug delivery, enhanced therapeutic efficacy, and compliance with regulatory guidelines.
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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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