Anything that is being manufactured has to go through the quality analysis process. This is severely necessary in the cases of the pharmaceutical and food industry too. Anything wrong and incorrect manufacturing of it can damage and sometimes cost the human life.
Good Manufacturing Practice a.k.a GMP certificate is a quality check certificate and is used globally. It helps control the quality of manufacturing, test it, and assuring the quality manufacturing of almost all pharmaceutical products.
This certificate defines the guidelines which assure the quality of the pharma products. A company holding GMP certification ensures that they follow all the necessary quality standard norms
Let us understand in detail about the GMP Certificate.
What is GMP?
We know that every certificate assures the value or the quality of something. These certifications and further legalizations of the same are required on the various stages of personal and professional life cycles. It provides the high authentication of the product, document, or services provided.
The same is the case with GMP certification. Like mentioned before about the GMP, it is a certificate issued mainly to the pharmaceutical and natural food manufacturers. It has a set of guidelines that affirm that the product is safe to use. Maintaining quality standards is of utmost importance in the medical industry. Any small mistake can affect the health of the user and may cause loss of life too.
Medicine and food are two fields that are directly related to human health. There shouldn’t be any scope of quality mistakes as it will hugely affect human life. To avoid this Good Manufacturing Practice Certificate comes with a set of guidelines to be followed by the manufacturing unit.
This certificate is responsible for the safety and quality of the product say medicine or the probiotic manufactured by a certain company. GMP also assures the usability and the quality of the medical devices too.
Let us understand how this term came into use
In 1968, WHO drafted the first text on GMP. Later in 1969, the first version of the WHO Certification scheme about the quality control on pharmaceutical manufacturing was recommended in the World Health Assembly.
The World Health Organisation then accepted GMP as the most integral part of the certification scheme. In the year 1991, the Expert Committee on Biological Standardization adopted an additional annex on biomedical products. It helped in establishing the proper system and created a general approach to the quality management of the medicines. WHO added the following things in this certification-
- Medicines
- Vaccines
- Blood and Related Products
- Cells and Tissue Therapies
- Antigens
- Biopharmaceutical Products
- Medical Devices
And many others
Many countries have adopted these provisions and concepts to define their own GMP guidelines. Also, 100+ countries have included WHO GMP as a standard in their medical laws. Even today, WHO GMP is used as a base for prequalification for the new vaccines for the approval of the aids from the UN agencies. That is a standard of which is being followed.
Now we know how the term GMP was formed and what value it has. We need to understand the procedure to proclaim the same.
What Is the Purpose of GMP?
Good Manufacturing Practice reduces the number of risk factors involved in pharmaceutical manufacturing. There are several risks involved such as-
- Unhygienic and uncleanliness in the product will affect the health and may lead to loss of life.
- Improper labeling on tablets or containers. It may imply that the patient takes incorrect medications.
- Accuracy of ingredients.
- Medicines causing an adverse effect
- Medicines not showing the determined results.
GMP regulates every aspect of the manufacturing starting from raw material, area of manufacturing, equipment involved, vicinity and sanity, training to staff, and their hygiene habits. It assesses the entire procedure until the final product arrives and will impact the quality of the pharma products.
How GMP Guidelines Help the Certificate Holders?
When the annexure was drafted, WHO stated certain guidelines for manufacturing practices. Various countries including India have structured their own GMP based on the guidelines from WHO GMP. Some countries have mandates in the form of associations such as the Association of South-East Asian Nations (ASEAN), in the European Union, and through the Pharmaceutical Inspection Convention.
This guideline is needed for the quality check of manufacturing. It eliminates the contamination, misinterpretations, misunderstandings, and errors from pharmacy manufacturing.
Many countries have framed their GMPs with extensive guidelines and open-ended aspects to it, some have allowed every manufacturer to select individuals on how to best manage the essential controls.
How GMP Benefits Pharmaceutical Manufacturing?
Every pharmaceutical and medical device manufacturer must follow the GMP guidelines or some countries have created their own guidelines. But in short, it is essential that there has to be a set of rules and regulations that will regulate the manufacturing of these needful products. Let us see how it is beneficial for the companies-
- It Ensures the Great Creation of the Product
- Identifying and Resolving Management and Manufacturing Related Issues
- Adherence to the Important Rules and Regulations
- Promotes the Credibility of the Products
- Positive Public Image
- Employee Safety Assurance
- Result-oriented Product Creation
- Increases Export Chances
- Reduces Manufacturing Risks and Hazards
- Avoids Duplication of Production Cost
- Reduces the Cost of Production
- Helps Avoid Penalties
- No Duplicate Inspections
Other than this one of the primary benefits for the manufacturer is that it significantly improves the quality of the product. The standard operating systems of the manufacturing units elevate to a high level. Many companies have seen significant growth in quality reports after receiving the GMP certification.
How Does It Benefit the Customers?
After all, the entire quality check is for the safety of the customers. It is for the customers to get the maximum benefit out of it. Customers know that when the manufacturer has a GMP certification they have a standard system in place. It provides evidence that high-quality medicines are produced. This assurance is not achieved through the one-day inspection, it is assured through multiple checking, audit reports, visits to manufacturing units, and many other processes involved before the actual GMP certificate is issued.
Let Us Understand the Step-by-step Process to Get the GMP-
- Application for the Certificate– A company has to fill in some basic information in the form to get the GMP certificate. The body accepts the application and maintains the records on the GMP database.
- Application Review– Once the application is submitted to the committee, it is reviewed by the concerned department. It ensures that all the necessary compliance is fulfilled.
- Gap Analysis and Quote– Once the documents are Okayed by the committee, the price quotations are provided and the gap analysis is performed to check for all the clauses. It also checks the gaps between the planned things, unplanned things, and achieved things too.
- Review of the Documents– The committee checks the documents provided by the organization which will fulfill the compliances.
- Actual Audit 1– The concerned committee evaluates the organization’s documents, procedures, policies, interacts with the employees if necessary. The audit report is then documented.
- Corrective Actions– The committee suggests corrective actions to get the GMP certificate.
- Verification– This step involves the verification of the documentation. The documents are checked so that all the standard requirements are maintained.
- Second Audit– This time the auditor checks the implementation of the proper process and if it is according to the documentation. If there is still a difference in documentation and implementation, the auditor gives another chance to correct the gap.
- Final Verification– It is checked if the company is following all the instructions and implemented them.
- Issuance of the Certificate– After the thorough audit and documentation of suggestions, and making sure that it is implemented, the committee grants the GMP certification to the company.
- Final Surveillance Audit-This audit is conducted to check if the organization is meeting the requirements of the quality management systems. It is generally scheduled half-yearly or yearly since the issuance of the certificate.
- Issuance of Re-certification– The company receives the re-certification if it maintains the procedure for continuous three years.
Does PEC Help in Getting the Legalization of GMP?
PEC Attestation and Apostille Services is the topmost Indian company that provides legalization services for all the important documents and certificates. Yes, it does help you in getting the legalization of GMP from Embassies and Chamber of Commerce units.
GMP Certificate Apostille is the process of obtaining the apostille sticker on the GMP Certificate. It is a part of the authentication of the desired apostille documents so that you can prove the credibility of the document and yourself.
Good Manufacturing Practice(GMP) Certificate is a government system designed for maintaining quality standards for products. It is primarily suitable for pharmaceutical corporations so that there is no error in the manufacturing procedure, otherwise, it can cause illness or sometimes death to patients. This practice ensures all things related to production-like materials, employees, work environment, hygiene.
What Process Does PEC Follow to Get the Legalization of GMP?
Certification agencies and companies are how you will get authentication for commercial documents. The apostille agents are proficient in performing the process of legalization and it is, therefore, facile to hire them for authentication of commercial documents. We here at PEC render you with the best services in India.
Our staff is skilled and has been operating for more than six years in the field of certificate legalization. PEC is trustworthy and dependable as well as well-verified to render legal services.
Obtaining an apostille seal on a certificate is an indirect and lengthy process. Earlier it was centralized to the Ministry of External Affairs (MEA), However, since January 1st, 2019, this process of legalization of the GMP certificates was decentralized to the branch secretaries and RPOs.
This has made common people’s approach to the consultancies convenient, however, it has also been lengthened. The procedure that is carried out today for authentication of documents is as follows:
Attestation of Chamber of Commerce Office- Chamber of Commerce is an organization of the local businessmen and authentication from this organization is the initial step for commercial document legalization. Commercial documents prove that your entrepreneurship is legal; hence, commercial document authentication helps in ratifying the same.
Getting an Apostille- Apostille in India, the procedure has recently been decentralized by the central government. The central body that carries out document apostille is the Ministry of External Affairs (MEA). The MEA has regionalized the apostille process to Branch Secretariats and the RPOs in 15 cities effective from January 1st, 2019.
The Cities of Operation Include– Ahmedabad, Bengaluru, Bhopal, Chennai, Chandigarh, Cochin, New Delhi, Guwahati, Hyderabad, Kolkata, Lucknow, Mumbai, Panaji, Raipur, and Thiruvananthapuram.
Generally, it begins at the local notary from where the document was issued and is followed by the state authentication and then the MEA apostille sticker. PEC apostille and attestation services have 6+ years of experience in getting commercial documents legalized.
EndNote- A Good Manufacturing Practice certificate is vital in the pharmaceutical industry. It assures that the company is following the standard procedures which ensure the quality of the manufacturing. Further legalization of it through the Chamber of Commerce and the MEA or Embassies ensures the document's authenticity.
Legalization processes of the personal, educational and commercial documents assure that the copy presented of the document is authentic and correct. In short, it is proof that the copy they are providing is a true copy. GMP certificates need it too. They have to prove to many customers, clients, and the international governments that the certificate they have is original.
When they try to tie up with the international manufacturers, they have to present the authentic copy of the GMP certificate. This authentication is to be done through the authorities from various concerned departments. Hence, GMP in itself holds value in the industry.
And the legalization process of the same further makes the document trustworthy. Experts at PEC attestation and apostille services are thorough about the legalization process, whether commercial, educational, or personal documents.
posted on 7 Jun, 2021.