Overview of GMP Certification
GMP stands for Good Manufacturing Practice, & the term is used globally for managing the control and management of manufacturing, testing and overall quality of pharmaceutical products. It defines certain guidelines that talks about the quality assurance approach. GMP certification ensures that products are produced following the quality standard norms.
Joint Commissioner is authorized by Commissioner, Food & Drug Administration, to sign & issue the certificates under the WHO-GMP certification scheme. GMP certification deals with issues like documentation, record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, sanitation, complaint handling, and process validation.
GMP requirements are not peculiar in any sense instead they are open ended and easy to implement also these requirements give liberty to the manufacturer to decide individually how to efficiently implement the necessary controls.
What is the Purpose of Goods Manufacturing Practice?
The main purpose of Goods Manufacturing Practice is to reduce the amount of risk involved in the production of pharmaceutical items. Pharmaceutical items include risks such as: (a) unexpected uncleanness in the product can badly affect the health which can further lead to death; (b) incorrect labels on containers which simply implies that patient is consuming the wrong medicine, (c) too much active or too less ingredient, (d) causing ineffective treatment or adverse effects, etc.
GMP has many authority under it such as covering all aspects of production, from the starting material, details regarding areas and equipment to the training and personal hygiene of staff. It provides the complete details regarding the procedures that yield the finished product and could affect the quality of it.
What does GMP Guidelines Directs the Certification Holders?
WHO (World Health Organization) has formed certain guidelines for good manufacturing practices. Numerous nations have defined their own necessities for GMP based on WHO GMP. Others have fit their prerequisites, for instance in the Association of South-East Asian Nations (ASEAN), in 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 instances of contamination, misunderstandings, and mistakes. This shields the consumer from buying an item which isn't compelling or even risky.
Most GMP prerequisites are extremely extensive and open-ended, permitting every maker to choose independently how to best actualize the essential controls. This gives a lot of adaptability, yet additionally necessitates that the producer decipher the prerequisites in a way which makes sense for every individual business.
What are the Benefits of GMP Certification?
Every pharmaceutical and medical device manufacturers follow GMP rules and procedures while some have created their own guidelines that correspond with their legislation.
- Benefits for the Manufacturer
One of the primary benefits 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 continuing during the years immediately following GMP certification.
- Benefits for the Customer
Customers will typically modify their oversight of manufacturers that have been GMP certified. Customers are aware that in order to be certified, the manufacturer must have systems in place and provide evidence that non-conformance and changes that require customer notification are handled appropriately. This assurance is typically not obtained through a one-day supplier audit that pharma companies carry out; rather, it is obtained as a result of thorough, multiple day audits of manufacturer as part of a certification audit program.
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What are the Documents Required for GMP Certification?
What is the Procedure to get GMP Certification?
This is the initial step to get the GMP certification; the application covers some essential data of the organization. The affirmation body must acknowledge the application and necessities to be record or keep up all the data on the GMP database.
- Review of Application
The application will be surveyed by the group to guarantee that the consistence necessity has been satisfied.
- Analysis & Agreement
After the audit of documents, give the value citation to plays out the Gap Analysis to cover all the provisos and area of the quality guidelines. The Gap Analysis is done to check the Gap between organizations arranged things and accomplished things.
- Documentation Review
Check the documentation of the organization to guarantee that the documentation is satisfied with the compliance prerequisite.
Calculate your associations recorded approach and strategies against the consistence requirement.
Then, review the documentation of your administration structure to guarantee that the consistence prerequisites have been settled down.
Corrective activity is to be managed by the non similarity. It has to be made when the noncompliance happens.
Verify the documentation of the establishment according to the standard required.
The inspector checks that the association as indicated by its documentation and the examiner of authoritative body distinguishes the non compliances, and at last the reviewer offers the chance to address the non compliances. After that, review the execution procedure as per the associations report.
If there is any non-similarity happens then the remedial move has to be made.
Verify work guidance and, then the execution process are being trailed by your representatives.
- Granting Of Certification
The Certification Body will give a certificate of compliance, which is substantial for a long time.
- Surveillance Audit
Surveillance review lead to guarantee that the association meets the prerequisites of the administration framework. Observation review must be acted in every six month or one year from the date of issued certificate.
What are the Consequences of GMP Non-Compliance?
When you work in any manufacturing industry, compliance along with good manufacturing practices is vital for your business. Not only it helps you make a high-quality product, but it also upholds consumer and ecological health. But, what happens if you don’t obey with GMP guidelines? Let’s take a glance at the consequences of the same.
- Strike to Reputation & Goodwill
For all businesses, the reputation is everything. It’s very important how you get the customers, gain product loyalty, and keep people coming to you every time. When you don’t obey with good manufacturing practices, your reputation is the first that will be hindered. Customers who don’t trust a manufacturer won’t take the risk of buying your products.
- Failure of Consumer Confidence
The good manufacturing practices guiding principle are in place to keep your clients safe. If you don’t pursue the guidelines, consumers with no trouble will lose confidence in your product. But the penalties are greater than just a business brake for your company.
- Criminal Prosecution
Food & Drug Administration, who issues the certificates under the WHO-GMP certification scheme, does have the ability to seize a drug & stop production through a court injunction. And, if the circumstances call for it, the Department of Justice and Health & Human Services also has the ability to follow actions against any manufacturing company that violate good manufacturing practices.
- License Cancellations
When dealing in manufacturing, there are ample numbers of licenses that go into the course. You need all of it, from building permits to licensed physicians till facility licenses. If you not succeed to comply with good manufacturing practices guidelines, you’re putting your work, your facility, and your physicians at danger for losing their license.
- Indictment of Fraud
Failure to comply with good manufacturing practices can also result in charges of fraud. This can come from issues with mislabeling ingredients or ingredient quantity or failing to advertise a product in compliance with good manufacturing practices guidelines. When a manufacturing company is accused of fraud, consequences can be severe.
The GMP guidelines specifically address fraud when it comes to labeling and branding practices. Consequences for failing to comply with these guidelines can be severe.
What are the Basic Principles that GMP Guidelines Seeks to Obey?
CorpBiz Procedure for GMP Certification
Kindly utilize the steps given above to integrate legally and securely a GMP Certification and get the benefits in the form of better-quality sales and satisfied clients. Our CorpBiz 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. CorpBiz professionals will assist you in planning seamlessly at the least cost, confirming 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. The Attorney will begin working on your request once all the information is provided, and the payment is received.
Frequently Asked Questions
There are various benefits that the GMP Certification be it to Manufacturers as well as customers, which are as follows:-
- Empower representatives to opt great creation
- Identify manufactures and management issues
- Compliance with laws and guidelines
- Increase credibility and public image
- Reduce safety risk in product quality and safety
- Increases consumer confidence in your products
- Helps to decrease operating costs due to rework and penalties due to non-compliance
- Helps boost export opportunities.
- Reduced duplication of inspections
- Cost saving
- CGMP refers to the ‘Current Good Manufacturing Practice’ guidelines authorized by the US Food and Drug Administration (FDA).
- ‘Good Manufacturing Practice’ (GMP) is a framework for guaranteeing that items are reliably delivered and controlled by quality guidelines.