GMP Certification

Good Manufacturing Practice (GMP) is a term familiar worldwide for the control and management of manufacturing, testing and overall quality control of food and pharmaceutical products. GMP is a set of guidelines & procedures that gives the assurance that product manufactured is appropriate and safe to use.

GMP procedure includes documentation, record keeping, process validation, employee qualifications, cleanliness, sanitation, equipment verification, and complaint handling. The majority of GMP requirements are universal and open ended, allowing each manufacturer to decide individually how to best apply the required controls.  

The standard procedures of GMP ensure manufacturing, enabling companies to reduce or eradicate instances of contamination, and production errors. Failure to fulfill with GMP regulations can result in very severe penalty including jail as well. 

A GMP (Good Manufacturing Practices) registration process make sure that the fundamental manufacturing practices/policies and standards for the implementation of a successful HACCP (Hazard Analysis Critical Control Point) food safety program are being followed.

GMP is a very efficient business tool, which helps to refine compliance and performance of the entire Company. GMP requirements are largely basic practices, which will help companies efficiently manage product quality using continuous improvement.

Nothing in a business is more crucial than quality control for a product sold. This is particularly crucial when it comes to consumer products that can't be step-by-step evaluated such as pharmaceuticals or nutritional supplements and due to this, it's important to confirm that a product's manufacturer is GMP-Certified, or Good Manufacturing Practice Certified. GMP certification includes documentation, record keeping, employee qualifications, cleanliness, sanitation, equipment verification, complaint handling, and process validation. A GMP Certificate assures that a particular product has been manufactured as per industry standards. Any organization seeking to lower the risk and liability that can arise from improper handling within a food operation must follow good manufacturing practices (GMP). 

• Improves brand promotion or image in the market
• To sustain quality management
• Provide instruction on how to produce safe to use and quality products.
• Increase customer satisfaction by deliver the safe and quality product and services.
• Develops motivation and team work between the employees of the organization.
• Managing production

The Objective of GMP Certificate

GMP's main objective is to reduce the amount of risk involved in the making of products at manufacturing units. All aspects of manufacturing are covered by GMP, including raw materials, specifics regarding locations and equipment, personnel training, and personal hygiene. It has all the details on the processes that lead to the finished product and could affect how well it turns out. A few of the risks involved in the manufacturing of the goods are as follows- 

• Unanticipated uncleanliness in the product can be fatal or have a bad effect on one's health
• Inaccurate container labelling that suggests the patient is taking the wrong medication
• An insufficient or excessive amount of an ingredient
• Ineffective therapy or negative side effects

Advantages of GMP Certification

Those industries certified under the GMP have the following benefits-

• It certifies that the organization manufacturing a product complies with the provisions mentioned under GMP and the WHO guidelines, or any other Nationalized Laws.
• GMP offers a clear production manual that ensures that goods meet the anticipated quality standards.
• Consumers of the product shall increase due to an increased level of trust in the authenticity and the standard the Company follows.
• It reduces the risk of quality issues in the product which reduces costs.
• It reduces rework and fines for non-compliance, which hence lowers operating costs.
• A company adhering to GMP guidelines for its products opens opportunities for exports.
• Increased quality of manufacturing systems and adherence to quality.
• The consumers receive safe and high-quality products.
• Encourages a healthy control system that enables a facility to uphold the highest standards of sanitization and cleanliness.

Legal Provisions

• The World Health Organization (WHO) has developed several recommendations for manufacturing best practices. Based on WHO GMP, several nations have developed their own GMP regulations. Others have fulfilled their obligations, including the European Union, the Pharmaceutical Inspection Convention, and the Association of Southeast Asian Nations (ASEAN).
• The certificate shall be kept in effect for at least two years after it is issued but no longer than three years after the inspection is completed.

Procedure to apply for WHO GMP License

• Application

The application asks for certain fundamental information about the business as it is the initial step toward gaining GMP certification. The application must be approved by the certification authority, and all information must be entered into or kept up to date in the GMP database.

• Evaluation

The application will be examined by the panel to make sure that the consistency criterion has been satisfied.

• Examination

To cover all the conditions and areas of the quality norms, act out the Gap Analysis after the document audit. The Gap Analysis is used to assess how efficiently tasks have been planned out and carried out in an organization.

• Conduct a review

Determine how consistent your organization needs to be with its documented approach and strategies.

• Refreshing Exercises

Corrective measures are the responsibility of the difference. It has to be sent right away after non-compliance.

• Double-check

Check the establishment's documents to make sure it complies with the requirements.

Process to get the GMP Certification

• Document collection by team Corpseed
• Gap Analysis by team Corpseed to cover all the clauses and section of the quality standards
• Document check to ensure that the documents fulfilled the compliance requirement.
• Initial Audit to review the company standards and plan corrective actions for non- conformity of standards
• Final audit by Corpseed auditor.
• Application submission to GMP authorities.
• Application review by authority to check all necessary parameters for GMP certification.
• Certification issued by authorities, which is valid for three years.

WHO GMP Certification in Maharashtra- (WHO GMP SCHEME)

Before awarding certifications, a Joint Inspection of Manufacturing Businesses by officers of the State Drugs Control Organization and a Zonal Officer from the Central Drugs Standard Control Organization should be conducted.

• Receipt of application

The applicant will first make an online application for Certification under the WHO–GMP Guidelines Scheme on the letterhead of the company, along with the Site Master File and other relevant data in the office of the Assistant Commissioner depending on the location of the factory. The following shall be submitted-

1. An undertaking that the manufacturing site is ready for inspection at the time of the application.
2. The details of the sections with a list of products to be covered under the certification.
3. Photocopies of licenses and the list of approved products.

• The second copy of the application along with its enclosures should be submitted within two days by the applicant to the Office of the Deputy Drugs Controller.
• Within 4 working days, the Assistant Commissioner must receive a complete inspection report in the required Proforma along with suggestions from the relevant FDA drug inspector. Within four working days, the Assistant Commissioner must provide the Licensing Authority with the aforementioned report, together with his comments and suggestions.
• After forwarding the application to the Certifying Authority, with the aid of the Drugs Inspector, Assistant Commissioner (Drugs) of WHO-GMP cell of the HQ, the Certifying Authority, i.e. the Joint Commissioner (HQ), FDA, Mumbai, must decide on the said application within 15 working days of the receipt of the said application.
• Joint Commissioner (HQ) is permitted to sign and issue certifications online following the WHO-GMP certification scheme by Commissioner, Food & Drug Administration, and Maharashtra State.

• Name of the applicant, including contact information (phone, fax, and email).
• Making Copies of Licenses
• Items that have been approved are listed.
• Site's primary database file (as specified under WHO TRS 823).
• Information regarding the final formulation
• List of technical staff members, together with information about their training, expertise, and level of approval.
• The tools and instruments that will be utilized.
• List of SOPs.
• A manufacturing plant's layout.
• A water system showing a circulation loop and MOC.
• An overview of the item as per the required format.
• Proof of effectiveness and safety as per Rule 158B of the 1945 Drugs and Cosmetic Rules.
• Pledging to abide by domestic laws such as the Drugs and Cosmetics Act of 1940 and its implementing Rules, the Drugs and Magic Remedies (Objectionable Advertisements) Act of 1954, and its implementing Rules

• Decreased Trust of Customers

To keep customers safe, good production practices have been established. If you ignore the advice, consumers will quickly lose faith in your goods. However, the repercussions go far beyond just being a hindrance to business.

• Reputation at Risk

Every company's reputation is incredibly important. It's crucial to think about how you attract customers, foster product loyalty, and encourage repeat business. The first thing to suffer when you don't adhere to basic production procedures is your reputation. Customers won't buy your stuff if they don't trust the producer.

• Criminal Charges

Through a court order, the FDA, which issues certificates under the WHO-GMP certification program, is legally able to seize a drug and suspend production. If the situation calls for it, the Departments of Justice and Health and Human Services also have the power to take legal action against any manufacturing company that fails to follow Good Manufacturing Practices.

• A pharmaceutical assembly office's manufacturing area needs to be kept hygienic and spotless.
• Monitoring the manufacturing process allows for the evaluation of any technique adjustments. Changes that affect the nature of the drug are approved as necessary.
• Records must be kept throughout the production process that show every step that was taken following the stated procedures and instructions, either manually or using instruments.
• The complete history of a batch may be tracked thanks to the maintenance of readable and accessible records of production and distribution.
• It is necessary to investigate complaints and take appropriate steps to address the problematic products and stop a recurrence.