GAP Analysis

GAP Analysis in Pharmaceuticals

GAP Analysis in Pharmaceuticals | GAP Analysis and Facility Assessment

Knors Pharma one of the leading pharmaceutical GMP audit consulting firm in India. The company is involved in providing auditing services such as GAP analysis in pharmaceuticals, GAP assessment in the pharmaceutical industry, GAP analysis and facility assessment, and GAP assessment in pharma industry, etc. GAP analysis is a way to compare current conditions and practices in order to identify gaps and areas in need of improvement with regards to compliance with the relevant standards, defined by Health Authorities (HAs).

Gap Analysis/Regulatory Assessment is used by all the pharmaceutical companies to analyze processes of any division of their company. In this process, we follow all the guidelines of all current practices and make a review for adequacy, suitability, effectiveness, compliance.

Here at Knors Pharma help to the pharma industries to identify all the Gaps and also help to find which process need to be fixed like quality management process, internal communications process, document control process, record keeping process, training process, internal audit process, management review process, measuring and monitoring process, monconformance management process, and continual improvement process.

In this way, an intensive gap analysis/specialized evaluation of the documents/data/information empowers the pharma manufacturers to distinguish and moderate the gaps before regulatory accommodation. It will keep away from Regulatory dismissals of the entries and limit the major/basic inquiries to attach the endorsements. Gap analysis of the legacy dossiers against current practices followed in the manufacture of the medicinal products.

  1. US 21 CFR 210-211 (cGMP), EU GMP part I and EU GDP for Medicinal products
  2. ISO 13485, US 21CFR 820, EU GMP Part 1 with Annex 10 for Sterile Medical Devices and Medical implantable devices
  3. EU GMP part II for API (ICH Q7) , EU GDP for API, US 21 CFR 210-211 (cGMP) for Active Pharmaceutical Ingredients, Pharmaceutical Intermediates, Pharmaceutical Raw Materials
  4. ISO 22716 for Cosmetic Ingredients
  5. ISO 15378, PS 9000 For Primary packaging for medicinal products
  6. ExciPAct, EU IPEC GMP, EU IPEC GDP for Pharmaceutical Excipients

Knors Pharma Solution auditors have cumulative auditing experience of more than 300 audits. Audit reports of our auditors are accepted across the globe and reviewed during regulatory inspections.

Professional GMP Audit & GAP Analysis Services by Knors Pharma

Knors Pharma is one of the most trusted drug development gap analysis companies in India. Our goal is to guide manufacturers toward achieving global excellence as their primary source of revenue; compliance is the foundation on which safety stands. Plus, our company is specially positioned to perform effective GAP analysis in pharmaceutical industry. This is helping businesses to bridge the gap between their existing operations and strict regulations. Our company’s professional auditors possess combined expertise from over 300 audits.

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GAP Analysis in Pharma Industry

What is GAP Analysis in Pharmaceutical Industry and Drug Development Process?

The drug gap analysis is a strategy assessment method whereby the various operational procedures of the pharma company are compared with the strict standards established by the WHO. Gap analysis is an audit of documentation, data, and product manufacturing details to identify the loopholes, or ‘gaps’, in compliance, suitability, or efficacy. By performing GAP analysis in pharmaceutical industry, the industry players can point out the location of the issues in the quality management systems. The audit of submitted documents related to current Good Manufacturing Practices (cGMP) is significant.

Why is gap analysis critical in drug development and the pharmaceutical industry?

Ensuring Unwavering Regulatory Compliance

In pharma industry-related frameworks, a GAP analysis in drug development is critical. This will ensure that there is compliance with the latest standards, such as US 21 CFR 210-211 and EU GMP guidelines. For instance, a pharmaceutical gap analysis may help in identifying potential risks of a lack of compliance in a company’s brand or products.

Optimizing the Drug Approval Procedure

A GAP analysis in pharmaceuticals is likely to allow companies to rectify data inconsistencies before the submission. Hence, by dealing with these “gaps” at the beginning, firms considerably lower the chances of major regulatory questions or refusals, which speeds the new drug’s development.

Optimizing Operational and Quality Systems

Beyond compliance, GAP assessment in pharma identifies process inefficiencies. It helps enhance how well quality management, document control, and communication processes work within the organization. This ensures that resources are being optimized and better-quality results are being produced because of optimized manufacturing cycles.

Strengthening Inspection Readiness

Regular GAP assessment in pharma maintains an “inspection-ready” frame at all times. We can fix any issues in training, GxP documentation, or monitoring processes by simulating the checks that health authorities would perform on companies. These improvements will ensure complete confidence during a regulatory inspection.

Enabling International Market Expansion

International firms need a GAP analysis and facility assessment to support their global expansion plans. It helps them assess if their existing dossier files satisfy certain conditions for various geographic markets based on certain mandates like ISO 13485/ICH Q7 guidelines.

What are the main challenges related to the gap analysis of pharma regulations?

Staying Ahead with Changing Regulatory Requirements
The ever-changing global regulatory environment makes it difficult for companies to keep pace with the constant stream of changes issued by the FDA, EMA, and other regulatory agencies. Many of them may have become noncompliant with the new safety standards.

Data Integrity and Management Challenges
Ensuring the integrity of the submitted information concerning the development stage could pose a challenge and remain a barrier. Inadequate record keeping or poor document management could cause gaps in the whole report, thus making the audit a difficult one.

Interpreting Technical Guidelines Accurately
The term employed by regulators is sometimes tricky and has different possible interpretations. Misunderstanding certain rules regarding sterile medical devices or API production can result in serious consequences. Such an error could lead to ineffective tests that hide serious problems in the company’s main operations.

Addressing Resource and Skill Constraints
A complete GAP analysis would call for specialized skills that are often absent in in-house units. Complex processes such as “non-conformance management” or “continual improvement” require the expertise of experienced auditors who understand the science and laws.

Why Choose Knors Pharma for Comprehensive Gap Analysis in Pharmaceutical Industry?

As the top pharmaceutical manufacturing consultants, Knors Pharma provides a thorough evaluation that helps companies identify and manage issues before they are approved by the relevant authorities.

At our agency, our team member adheres to recent trends to analyze your quality management system, training process, and document control practices to a certain degree of adequacy and appropriateness.

Our reports are widely accepted around the world during major inspections. We have experience analyzing requirements from US 21 CFR 210/211 to ISO 15378, having completed over 300 audits across the globe.