Partner with Experts in Compliance
Acknown Pharma specializes in pharmaceutical quality assurance, regulatory compliance, and quality control. Our expert team delivers detailed Drug Master File (DMF) preparations, regulatory dossier compilations (CTD, eCTD, ACTD), GMP consultation, residual impurity studies, stability zone classifications, and thorough compliance audits. We support pharmaceutical companies in meeting FDA, EMA, and global regulatory standards to ensure safe and effective products.
Quality & Compliance Services for Pharmaceuticals
GMP Audits (API & Finished Dosage Form)
We conduct detailed GMP audits for both APIs and finished dosage forms, ensuring your manufacturing processes are compliant with international GMP requirements. Our rigorous audits identify risks, recommend actionable improvements, and strengthen your compliance posture.
Triggering Plant GMP Compliance
We conduct detailed GMP audits for both APIs and finished dosage forms, ensuring your manufacturing processes are compliant with international GMP requirements. Our rigorous audits identify risks, recommend actionable improvements, and strengthen your compliance posture.
Qualified Person (QP) Services for EU
We provide highly experienced Qualified Person services, essential for releasing pharmaceutical batches within the EU. Our QP experts certify compliance with all relevant regulations, ensuring your products maintain integrity from manufacturing to market.
Release and Testing Services
Our comprehensive testing and batch release services ensure that each product meets stringent quality specifications and regulatory requirements, reducing risks and enhancing product reliability and patient safety.
Frequently Asked Questions for Quality Services
What is a Drug Master File (DMF)?
A DMF is a confidential document submitted to regulatory authorities providing detailed information about the facilities, processes, and components used in manufacturing, processing, and packaging pharmaceutical products.
What are the types of DMFs?
There are five types:
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Type I: Manufacturing Site, Facilities, Operating Procedures, Personnel
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Type II: Drug Substance, Drug Substance Intermediate, or Material Used in Their Preparation, or Drug Product
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Type III: Packaging Material
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Type IV: Excipient, Colorant, Flavour, Essence, or Material Used in Their Preparation
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Type V: FDA Accepted Reference Information
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When is a DMF required?
A DMF is submitted when a manufacturer or supplier needs to share confidential product information with regulatory authorities, which cannot be disclosed in a drug application (NDA or ANDA).
What are the open and closed parts of a DMF?
A DMF includes an open part suitable for public disclosure, containing administrative details and summaries of the manufacturing process, and a closed part holding proprietary, confidential details such as manufacturing processes, quality control, stability data, and specifications.
What information is included in the open part of a DMF?
The open part typically contains administrative information, the identity of the DMF holder, drug substance or product descriptions, and manufacturing process summaries without confidential details.
What information is included in the closed part of a DMF?
The closed part includes proprietary manufacturing processes, quality control measures, detailed stability data, and specific product specifications crucial for competitive advantage.
What is a residual study in pharmaceuticals?
A residual study evaluates trace substances like impurities or contaminants remaining in drug products post-manufacturing to ensure they fall within safe regulatory limits.
What types of impurities are assessed in residual studies?
Impurities include organic solvents, heavy metals, nitrosamines, degradation products, and process-related contaminants from raw materials, solvents, or storage degradation.
What methods are used in residual studies?
Analytical methods such as High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Mass Spectrometry (MS), and Liquid Chromatography-Mass Spectrometry (LC-MS) are commonly used to identify and quantify impurities.
What services are typically included in GMP consultation?
GMP consultation services typically include GMP audits, gap analyses, SOP development, training, facility design recommendations, process validation, and regulatory inspection support.
What is stability zone classification in pharmaceuticals?
Stability zones categorize global climates relevant to drug product storage and distribution, guiding environmental conditions used in stability testing to ensure product safety, quality, and efficacy.
What is the purpose of stability testing in different zones?
Stability testing ensures a pharmaceutical product maintains its quality standards under defined environmental conditions throughout its intended shelf life, effectively catering to regional climatic variations.