GMP certification deals with issues like documentation, record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, sanitation, complaint handling, and process validation.
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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.
- Empower certification holders to opt great creation,
- Timely identify of manufactures and the management issues,
- Compliance with important laws and guidelines,
- Improve overall 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.
- 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.
What are the Documents Required for GMP Certification?
- Name of the applicant with address, telephone, fax, e-mail etc.
- Copy of Manufacturing License.
- List of approved products.
- Site Master file (as specified under WHO TRS 823).
- Data on Finished Formulation:-
1. Master manufacturing formula, manufacturing process.
2. Finished product specification and Method of Analysis.
3. Stability study evaluation (Accelerated and Real Time) for 3 batches including details batch size, Batch No., Date of manufacturing, Date of Expiry, stability study condition (Accelerated/ Real time),
4. Process validation report for 3 batches.
5. Validation report of analytical method.
- List of technical staff, their qualification, and experience and approval status.
- List of equipment and instrument.
- List of SOPs and STPs.
- Manufacturing Plant layout.
- Schematic diagram of water system specifying circulation loop and MOC.
- Product summary sheet (as per Format B).
- Proof of safety and effectiveness as per Rule 158B of Drugs & Cosmetic Rules, 1945.
- Undertaking regarding compliance to the provisions of domestic regulations inter-alia Drugs & Cosmetics Act, 1940 and Rules thereunder, Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules there under, etc.
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.
3. Restorative Activity
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.
2. Restorative Action
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?
- Pharmaceutical assembling office must maintain their manufacturing zone clean and spotless. Controlled ecological conditions should be maintained so as to prevent cross contamination of nourishment or medication item from adulterants that may render the item perilous for human utilization.
- Manufacturing process is unmistakably characterized and controlled. Every single procedure must be approved to guarantee consistency with details.
- Manufacturing processes are controlled, and any progressions to the procedure are assessed. Changes that affect the nature of the medication are approved as per requirement.
- Directions and techniques are must be written in clear and unambiguous manner. Administrators must be prepared to conduct document procedures.
- Records must be made, manually or by instruments, during manufacture that demonstrates all the steps required by the defined procedures and instructions Moreover, all deviations are to be investigated and documented.
- Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.
- Complaints about items are to be analyzed, where the reasons for quality imperfections must be investigated and suitable measures are taken concerning the inadequate items & to prevent repeatation.
ApkaTax Procedure for GMP Certification
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Frequently Asked Questions
Joint Commissioner is authorized by Commissioner, Food & Drug Administration, to sign & issue the certificates under the WHO-GMP certification scheme. GMP certification is given based on a finished GMP assessment of a producer working as per the GMP guidelines. The authentication is given that satisfactory documentation on the examination follow-up is submitted.
The application for GMP certification must be made by an approved individual within the organization looking for the confirmation. This is typically one with obligation, for example, a Production Manager, a Quality Assurance Manager, a Quality Control Manager or the Managing Director.
Good quality can be assured during the manufacturing process afterwards it is not possible to test it. GMP protects the final product from errors that cannot be ignored through quality product. Without GMP it is difficult to be certain that each unit of a medication is of a similar quality as the units of medication tested in the research facility.
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
The primary objective of GMP is to reliably deliver great medications or clinical gadgets that fulfill the global guidelines required for capably oversaw medicinal services. Procedures utilized in manufacture are deliberately controlled, and any progressions to the procedure must be assessed.
The certification is normally legitimate for a time of three years.
The purpose of inspecting pharmaceutical manufacturing offices is either to implement Good Manufacturing Practice (GMP) consistence or to give approval to the manufacturing of explicit pharmaceutical items, generally corresponding to an application for marketing approval.
- 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.
Denied quality medications are not only create health danger, however a misuse of cash for the two governments and individual buyers. GMP is designed to guarantee that mistakes don’t happen. Execution of GMP is an interest in great quality medications.