Overview

GMP Certification

GMP stands for Good Manufacturing Practices, and the term is used globally to describe the manufacturing, testing, and overall quality control and management of pharmaceutical products. It defines some guidelines that talk about a quality assurance approach. GMP certification ensures that the products comply with the quality standard norms.

The Joint Commissioner is authorized by the Commissioner of Food and Drug Administration to sign and issue certificates under the WHO-GMP Certification Scheme. GMP certification deals with issues such as documentation, record keeping, personnel qualification, sanitation, cleanliness, equipment verification, sanitation, complaint handling and process verification.

What is the Purpose of a Good Manufacturing Process?

The main objective of a goods manufacturing practice is to reduce the amount of risk involved in the production of pharmaceutical items. Pharmaceutical goods involve risks such as:

1. Unforeseen impurities in the product may cause serious health effects that may lead to death;
2. Mislabeling on containers, which means that the patient is taking the wrong medicine,
3. Too much active or too little ingredient, (d) ineffective treatment or adverse effects, etc.

GMP has many rights under it such as covering all aspects of production, from starting material, details about areas and equipment to training and personal hygiene of employees. It provides complete details about the processes that produce the finished product and may affect its quality.

What does GMP Guidelines Directs the Certification Holders?

WHO (World Health Organization) has made some guidelines for good manufacturing practices. Many countries have defined their requirements for GMP based on the WHO GMP. Others have met their prerequisites, for example, in the Association of Southeast Asian Nations (ASEAN), the European Union, and through the Pharmaceutical Inspection Convention.

GMP guidelines require a quality way to deal with manufacturing, empowering organizations to limit or eliminate contamination, misunderstandings and mistakes. It protects the consumer from buying an item that is not compelling or even risky.

Most GMP prerequisites are extremely comprehensive and open-ended, allowing each manufacturer to independently choose how to best implement the required controls. This allows for a lot of customizability, yet requires that manufacturers understand the prerequisites in a way that makes sense for each individual business.

What are The Benefits of GMP Registration?

Each drug and medical device manufacturer follows GMP rules and procedures while some have created their own guidelines that are in line with their legislation.

• Empowering certification holders to opt for great creation,

• Timely identification of manufacturers and management issues,

• Compliance with important laws and guidelines,

• Improving overall credibility and public image,

• Reduce the safety risk in product quality and safety,

• Increases consumer confidence in its products,

• Helps reduce operating costs due to resale and penalties due to non-compliance,

• Helps in promoting export opportunities,

• Reduction in duplication of inspections

• Money saving.

• Benefits For The Manufacturer
  One of the primary advantages is significantly improved quality systems and quality compliance at the manufacturer. We have seen these improvements in the months leading up to GMP certification and have continued during the years immediately following GMP certification.

• Benefits For The Customer
  Customers will typically modify their monitoring to manufacturers that have been GMP certified. Customers are aware that in order to be certified, the manufacturer must have the system in place and provide evidence that non-conformance and changes requiring customer notification are handled appropriately.This assurance is generally not achieved through the one-day supplier audits that pharma companies perform; Rather, this certification is achieved as a result of a thorough, multiple-day audit of the manufacturer as part of the audit program.

Documents Required for GMP Certification?

• Name of the applicant including address, telephone, fax, e-mail etc

• Copy of manufacturing license.

• List of approved products.

• Site master file (specified under WHO TRS823).

• Data on ready formulation :-

  1. Master manufacturing formula, manufacturing process.

  2. Finished product specification and method of analysis.

  3. 3. Sustainability Study Evaluation (Quick & Real Time) for 3 batches including details Batch Size, Batch Number, Manufacture Date, Expiry Date, Sustainability Study Status (Quick / Real Time).

  4. Process verification report for 3 batches.

  5. Verification report of analytical method.

• List of technical staff, their qualifications, and experience and approval status.

• List of tools and equipment.

• List of SOPs and STPs.

• Manufacturing Plant Layout.

• Schematic diagram of the water system specifying the circulation loop and MOC.

• Product Summary Sheet (as per Format B).

• Proof of safety and effectiveness as per Rule 158B of the Drugs and Cosmetics Rules, 1945.

• The Drugs and Cosmetics Act, 1940 and the Rules thereunder, the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and the Rules thereunder, etc., with regard to compliance with the provisions of the Household Regulations, inter alia.

What is the process to get GMP Registration?

Application

This is the initial step for obtaining GMP certification; The application contains some essential data of the organization. The confirmation body must record the application and requirements or keep all data on the GMP database.

Review of Application

The application will be surveyed by the group to guarantee that the continuity requirement is met.

Analysis & Agreement

After the documents are audited, give a price quote to run the gap analysis covering all the provisions of the quality guidelines and the area. Gap analysis is done by organizations to investigate the gap between the things systematically and proven things.

Documentation Review

Check the organization's documentation to ensure that the documentation meets the compliance condition.

• Stage-1
  1. Audit

     Fully online, paperless, and contactless platform

  2. Survey

     Then, review your governance framework documentation to ensure that the continuity prerequisites have been set.

  3. Restorative Activity

     Corrective activity is to be managed by non-equality. It will have to be made if there is non-compliance.

  4. Check

     Verify the documentation of the establishment as per the required standard.

• Stage-2
  1. Audit

     The inspector checks that the association as indicated by its documentation and the official body's examiner distinguishes non-compliances, and finally provides the reviewer the opportunity to address the non-compliances. After that, review the execution process as per the report of the association.

  2. Restorative Action

     If any non-similarity happens then the remedial move has to be made.

  3. Check

     Verify work guidance and, then, the execution process is being followed by your representatives.

  4. Granting of Certification

     The certification body will give a certificate of compliance, which is enough for a long time.

  5. Surveillance Audit

     Monitoring review guarantees that the association meets the prerequisites of the governance framework. Observational review should be done every six months or one year from the date of issue of the certificate.

What are the Consequences of GMP Non-Compliance?

When you work in any construction industry, compliance with good construction practices is vital to your business. Not only does it help you produce a high quality product, but it also maintains consumer and ecological health. But, what if you don't follow the GMP guidelines? Let's take a look at the results of the same.

• Strike To Reputation & Goodwill

  For all businesses, reputation is everything. It is very important how you acquire customers, gain product loyalty, and keep people coming to you every time. When you don't follow good manufacturing practices, your reputation will be the first to suffer. Customers who don't trust a manufacturer won't take the risk of buying your products.

• Failure of Consumer Confidence

  Good manufacturing practices are the guiding principle to keep your customers safe. If you don't follow the guidelines, consumers will lose trust in your product without any hassle. But the penalty is more than just a business break for your company.

• Criminal Prosecution

  The Food and Drug Administration, which issues the certificate under the WHO-GMP certification scheme, has the ability to confiscate the drug and stop production through a court order. And, if circumstances so demand it, the Department of Justice and Health and Human Services has the ability to follow up with action against any manufacturing company that violates good manufacturing practices.

• License Cancellations

  When working in manufacturing, there are a substantial number of licenses that go into the curriculum. From building permits to licensed practitioners to facility licenses, you need it. If you do not succeed in following the Good Manufacturing Practices guidelines, you are putting your work, your facility and your physicians at risk for losing your license.

• Allegation of Fraud

  Failure to follow good manufacturing practices can also result in charges of fraud. This may be due to mislabeling material or ingredient quantity issues or by failing to advertise a product in compliance with good manufacturing practices guidelines. When a construction company is accused of fraud, the consequences can be dire.

What are the Basic Principles that GMP Guidelines Seeks to Obey?

• The pharmaceutical assembling office should maintain its manufacturing area clean and spotless. Controlled ecological conditions must be maintained to prevent cross-contamination of a nutritional or pharmaceutical item with adulterant substances that may be hazardous to human use.

• The manufacturing process is unmistakably characterized and controlled. Every single process must be approved to guarantee uniformity with details.

• Manufacturing processes are controlled, and any progress in the process is evaluated. Changes affecting the nature of the drug are approved as and when required.

• Instructions and techniques should be written clearly and clearly. Administrators must be prepared to conduct document processes.

• During construction, records must be made, manually or by equipment, showing all the steps required for defined procedures and instructions. In addition, all deviations are to be investigated and documented.

• Manufacture records (including delivery) are kept in an intelligible and accessible form, which enables tracing the entire history of a batch.

• The complaints about the items are to be analyzed, where the reasons for the quality defects should be investigated and in respect of insufficient items, suitable measures should be taken to prevent further repetition.

LegalTax Procedure for GMP Certification

Please use the steps above to legally and securely integrate GMP certification and benefit in the form of better quality sales and satisfied customers. Our LegalTax experts will be at your disposal for assisting you with guidance concerning GMP Certification and its compliance for the smooth functioning of your manufacturing business in India. LegalTax professionals will assist you in planning seamlessly at the least cost, confirming and the successful conclusion of the process.

It is advisable that an attorney with “corporate certification experience” must be appointed to overwhelm many of the potential pitfalls that creep around within GMP Certification and to understand the requirement in detail. The elementary information would be mandatory from your end to start the process once all the information is provided, and the payment is received.

Why To Choose LegalTax?

LegalTax is one of the platforms which Coordinate to accomplish all your legal and financial requirements and connect you to Consistent professionals. Yes, our clients are satisfied with our legal service! Because of our focus in simplifying legal requirements, they have consistently regarded us highly and provide regular updates.

Our customers can also track progress on our platform at all times. If you have any questions about the GMP certification process, our experienced representatives are just a phone call away. LegalTax will ensure that your communication with professionals is engaging and seamless.