GMP Certification

Introduction

To ensure that products are consistently manufactured and controlled according to predefined quality standards there is a globally recognized quality assurance certification designed i.e. Good Manufacturing Practices (GMP) Certification. To safeguard product safety, efficacy, and quality GMP focuses on minimizing risks during the production process. It is especially requisite in industries such as pharmaceuticals, food and beverages, cosmetics, medical products, biotechnology etc.

To gain trust among consumers, regulators, and stakeholders, obtaining GMP Certification is critical to demonstrate your commitment to high-quality manufacturing standards whether you are an established manufacturer or a startup

What do you mean by GMP Certification?

GMP Certification implies that a company must follow the strict guidelines and procedures through production. It comprises guidelines concerning the production, equipment, personnel, hygiene, and documentation of manufacturing processes.

The purpose of GMP Certification is to:

• Confirm that the products are safe for the use of consumer.
• Quality of product across batches must maintain consistency.
• For export comply with international regulatory requirements.

GMP covers everything from the training of employees and cleanliness of facilities to the recordkeeping and calibration of machines

Why is GMP Certification needed?

Getting a GMP Certification is not just a business imperative but also a regulatory requirement.

Prose of GMP Certification:

• Regulatory Compliance: The certificate assures that the manufacturers or importers smoothly run their business in the foreign market and avoid being barred from the market both domestically and internationally.
• Consumer Confidence: Certification in relation to the product ensures that it is fulfilling the quality standards and complying with the statutory regulations with respect of safety and performance that helps to achieve customer trust in the said product.
• Market Access: The Products with GMA certification can freely circulate within the U.S, EU and other countries without any hindrance as it fulfils regulations. It is significant for exporting products.
• Risk Reduction: Evades heavy penalties, legal problems, and probable business closings due to non-compliance.
• Global Recognition: The certification helps brand to achieve brand recognition and make it unique from the competitors.
• Avoid getting in bizarre situations like getting heavy penalties, banned from market or jail time in case of non-compliance by fulfilling the certification process.

Eligibility Criteria

Industries involved in manufacturing, processing, or handling products that require stringent quality standards are applicable to apply for GMP Certification.

Who can apply?

• Pharmaceuticals
• Food and beverages
• Cosmetics
• Medical products
• Biotechnology
• Any business i.e. involved in consumer product business required regulatory approval

To meet GMP requirements companies must have their production processes, facilities, and documentation in place.

Documents Required

Below are the documents mentioned that you need for the application of GMP certification:

• Certificate of incorporation, PAN, GST, etc.
• Manufacturing License for Relevant industry-specific licenses
• Quality Manual
• Standard Operating Procedures (SOPs) that contains a detailed guidelines for all manufacturing and operational activities
• Equipment Calibration Records
• Records in relation to training of employees
• Production record
• Raw material procurement record
• Blueprint of the facility
• Records of cleanliness standards and pest control measures

Based on industry and product type additional documents may be required.

Step-by-Step Process

The process of getting the GMP Certification includes the following steps:

• 1. Primary Assessment:
  Estimate your current manufacturing performance against GMP requirements.
  Identify areas of improvement and fill up the gaps.
• 2. Preparation of documents:
  Prepare the draft and keep updated the required SOPs, Quality Manuals, and other related documents.
• 3. Facility Upgrade (if necessary):
  To align with GMP standards make changes to the production facility.
  Confirm proper hygiene, disposal of waste and equipment calibration.
• 4. Training of employee:
  To educate employees on GMP protocols conduct training programs.
• 5. Submit Application:
  After arranging the documents file the application with the concerned authority.
• 6. Pre-Approval Inspection:
  To ensure your facility meets the required standards undertake an internal audit inspection.
• 7. GMP audit by certified authority:
  Conduct audits (if necessary), and request additional information if required this way the GMP will review your application.
• 8. Address non-conformities:
  During the review process if any deficiencies identified rectify it and submit again.
• 9. Certification Issuance:
  If everything is satisfactory the certificate will be issued
• 10. Annual Audit:
  To retain certification, maintain compliance through periodic audits.

Timeline

Generally, the timeline for obtaining the certification GMP certification takes 3 to 6 months once the application is submitted but, in some situations, it may take slightly a longer duration.

Fees and Costs

The cost for getting GMP Certification varies due to following reasons:

• Govt. fees: Fees taken by the GMP for registration.
• Professional Fees: If you are seeking the guidance of a professional for the application of the certificate then their fees will be added.
• Cost of training: To train the employees a separate cost will be charged.
• Facility cost: To upgrade the facility if there is a requirement.

The total cost can vary, depending on the product type and scope of work.

Penalties for Non-Compliance

If you fail to get the GMP Certificate you may face dire consequences such as:

• Seizure of product: The authorities may seize the products if it is found that it is violating the regulations.
• Lawful Action: Without license engaging in the business may result in heavy fines and imprisonment in case of repeaters.
• Market banned: If you do not have GMP certificate it can result in banning of your business from the market.
• Tarnish of reputation: Selling products without license or certificate will tarnish the reputation of your brand, leading to customer doubt and forfeiture of market share.

Why Choose Us?

Certilize is your trusted partner for FDA Certification, ensuring a seamless and stress-free experience.

Why partner with us?

• At Certilize, we have experts that helps to guide the businesses through the multipart GMP Certification process. The reason listed below answer your query that why you should choose us:
• Specialization: We specialize in helping individuals and businesses with application process.
• Start-to-End Support: From documentation to final approval, we handle the entire process.
• Cost-effective: Pricing is very competitive and there are no hidden charges, making it beneficial for individuals and businesses.
• Quick Processing: Your application is processed fast, generally 2-3 days creamy.
• Experience: We have applied for many businesses which has given us experience and knowledge to deal with any technicalities.

Contact Certilize today to discuss your product and begin the GMP Certification process.

For hassle free application of GMP certificate join us and let our team take the burden of the complex process. We have experience and have capability in fulfilling the task in hand within the required time frame