WHO-GMP Certification

Introduction

In the healthcare and pharmaceutical business, quality ratings play an important role in patient safety and being accepted in the global market. WHOGMP Certification (World Health Organization – Good Manufacturing Practices) is a worldwide accepted certification defining the standards of production and control of pharmaceutical products.

The WHOGMP Certification is an indicator that a business establishment is operating at the utmost levels of production with regard to product quality, safety, and performance. Pharmaceutical manufacturers need this certification, assuming that they are willing to expand and win the trust of regulators, healthcare providers, and general consumers all over the world.

What means WHOGMP Certification?

WHOGMP Certification refers to guidelines on quality assurance that the World Health Organization (WHO) developed so as to help pharmaceutical products to be always manufactured and regulated in line with the pharmaceutical quality.

Major aspects of WHOGMP Certification are the following:

• To ensure that manufacturing processes get designed, monitored, and controlled effectively.
• Instituting structures to curb contamination, cross-contamination, and deviation in quality.
• Monitoring so that the products are safe to consume and correspond to their appropriate use.
• Improving performance and process fulfillment of international regulatory rules.

These manufacturers of pharmaceuticals, biotech companies, and manufacturers of healthcare products across the world can get certified.

What is the need for WHOGMP Certification?

WHOGMP Certification is not just a regulatory aspect in most countries, but it is also a business necessity for firms within the pharmaceutical and healthcare industry.

WHO-GMP Advantages of Certification:

• Market Access: The export of pharmaceuticals to a number of countries requires adherence to WHOGMP requirements.
• Quality Assurance: Quality assurance increases the efficacy and reliability of the products you produce and ensures safety.
• Regulatory Compliance: It assures compliance based on the health laws that are enforced in various parts of the world.
• Brand Credibility: To create faith and trust with the regulators, health professionals, and consumers.
• Competitive Edge: It can make your business to be that what it is in a competitive market.
• Operational Efficiency: Maximizes business practices and minimizes wastage.

Lack of WHOGMP Certification means loss of business opportunities, legal discipline, and loss of reputation.

Eligibility Criteria

WHOGMP Certification can be applied to companies that engage in the manufacture, processing, and packaging of pharmaceutical products.

Who is eligible?

• Drug companies and tech companies that make medicine and vaccines.
• Producers of nutraceutical and dietary supplements.
• Manufacturers of cosmetic products who need medicinal claims.
• The manufacturers of API (Active Pharmaceutical Ingredients).

The claimants should show that they have complied with the WHO recommendations as well as the facilities they have must be up to the standard.

Documents Required

In order to apply for WHOGMP Certification, you will be required to submit a very detailed list of documentation:

• Business Registration Documents: Certificate of registration of the company, GST registration, and so on.
• The manufacturing license: License given by the corresponding drug control authority.
• Site Master File: Description of manufacturing facility, manufacturing process, and quality systems in detail.
• Product Dossiers: Information regarding the products, such as formulations, manufacturing procedures, and specifications.
• Standard Operating Procedures (SOPs): Records of work procedures towards every process.
• Quality Control Records: Documentation of testing of products, calibration cover, and product validation.
• Personnel Records: Data on staff qualification, training, and positions.
• Facility Layout and Equipment Details: flow charts and details of the plant and equipment.

The requirement of documentation can be different based on the nature of the products and the certifying body.

Step-by-Step Process

Here’s a detailed guide to obtaining WHOGMP Certification:

• Pre-Assessment Audit: Carry out an internal inspection of your operations, records, and premises to highlight some gaps.
• Document Preparation: Collect and organize the necessary documents, such as the Site Master File and SOPs.
• Application Submission: File the application and other required documents to the certifying authority.
• Audit and Inspection: The certification agency carries out a critical audit of your plant, monitors the processes and quality systems, and confirms the WHOGMP requirements.
• Non-Conformance Rectification: Respond to identified non-conformities in the course of the audit and take corrective measures.
• Certification Approval: When compliance has been confirmed, the certifying authority then issues the WHOGMP Certificate.
• Renewal and Surveillance Audits: The WHOGMP Certification usually has to be periodically renewed or concurrently monitored in terms of compliance.

Timeline

Time of gaining WHOGMP Certification: This will take a more extended period, depending on the complexity of the operations you are involved in and the readiness of the facility.

• Document Preparation: 2-4 weeks.
• Audit and Inspection: 4-8 weeks.
• Certification Issuance: 1-2 weeks post-approval.

Overall, it can take a period of 2-4 months to complete.

Fees and Costs

The price of WHOGMP Certification depends on the facility (size), product type, and the certifying entity.

Cost components include:

• Application Fees: Paid to the certifying authority.
• Audit Fees: The cost of carrying out onsite examinations and evaluation.
• Consultancy Charges: Payments due to experts in creating documentation and maintaining that compliance.
• Renewal Costs: Costs that require periodical renewals of the certification.

The overall expense is about $5,000 to 20,000, based on the extent of the certification.

Penalty on Non-Compliance

Lack of attainment and renewing WHOGMP Certification may result in:

• Market Restrictions: Loss of possibility to sell goods at a regulated market.
• Legal Sanctions: Law or penalties by the regulatory bodies.
• Product Recalls: Provision of the recall of the non-compliant goods.
• Loss of Reputation: Loss of consumer and stakeholder confidence.

Why Choose Us?

We are a Certilize agency that can do just that since we know how to streamline the WHO-GMP Certification process without it being problematic and stressful to our clients.

What makes us different?

• Subject Matter Expert: Our members are well-versed in WHOGMPs and regulations.
• End-to-End Support: We take care of every step, which includes the preparation of Documents and audit support.
• Personalized Services: Special services to suit your specialized business.
• Trusted Network: Building partnerships with certified certification organizations to facilitate an easy certification process.
• Fast Turn-around: Effective systems to reduce stalling and be able to certify at the right time.

Fertilize gives you the possibility to concentrate on your own business and leave your compliance needs to our services.

Certilize: You Certified Partner in WHOGMP Certification

Reach out to us now to make yourself compliant with WHOGMP standards and compete in the global market!