The Top WHO CGMP Pharmaceutical Manufacturers in India You Need to Know

WHO CGMP or Good Manufacturing Practices (GMP) is a certification given by the World Health Organization (WHO) that ensures pharmaceutical manufacturers adhere to quality standards and norms set by a global health agency. It provides guidance on manufacturing processes and maintaining quality control of pharmaceutical products. 

WHO CGMP certification has become extremely important for pharmaceutical companies in India for the following reasons:

• It demonstrates a commitment to best practices and high quality standards in drug manufacturing. With India being one of the largest global suppliers of generic medicines, WHO GMP is critical for maintaining quality and reputation.
• It helps meet regulatory requirements for exports. Many countries will only accept import of pharmaceuticals from WHO GMP approved facilities. The certificate is often needed to register products and participate in foreign tenders.
• It builds trust and credibility with customers. WHO GMP approval provides assurance to buyers that the company’s facilities and processes meet excellent quality levels endorsed by WHO. This boosts confidence in products.
• It improves export potential and access to more markets. WHO GMP certified companies gain easier entry into regulated markets like US, Europe, Japan etc. where these standards are mandatory.
• It ensures a quality culture within the organization. Getting WHO GMP requires comprehensive evaluation of all systems and processes, leading to overall quality improvements in the company.

In summary, WHO CGMP certification demonstrates a pharmaceutical company’s commitment to best practices and helps improve quality, trust, and export competitiveness. It is a mark of excellence that holds great significance for drug makers in India.

India’s Leading WHO GMP Certified Pharma Companies – History and Origins

The World Health Organization (WHO) introduced Good Manufacturing Practices (GMP) in 1967 to ensure quality and safety in the production of pharmaceutical products. The initial guidelines focused on inspection, documentation, personnel, equipment, materials, and premises. 

Over the years, the WHO has revised and expanded the GMP guidelines to keep up with scientific and technological advances. 

Some key events in the evolution of WHO GMP standards include:

• 1975 – Expanded to cover sterile products manufacturing 
• 1989 – Guidance on quality control laboratories introduced  
• 1992 – Revised to include good distribution practices
• 1995 – Quality systems approach incorporated
• 1997 – Guidance on active pharmaceutical ingredients manufacturing added
• 1999 – Guidelines made more comprehensive based on industry feedback
• 2003 – Annexes added on herbal products and radiopharmaceuticals

The reasons behind introducing WHO GMP were to:

• Protect public health by minimizing risks from pharmaceutical products
• Ensure products are consistently produced to quality standards
• Build confidence in pharmaceutical goods worldwide 
• Provide unified global benchmarks for regulators and manufacturers
• Outline best practices for quality assurance and quality control
• Prevent substandard, unsafe, contaminated or counterfeit medicines from reaching patients
• Promote transparency, consistency and compliance across the pharmaceutical industry

WHO GMP helps ensure medicines are safe, effective, and of high quality. The guidelines have evolved over 50+ years to incorporate current science, technology and risk management principles. WHO GMP certification demonstrates a company’s commitment to product quality and patient safety.

Benefits of WHO CGMP Certification

WHO GMP certification demonstrates a company’s commitment to quality and safety. It brings several important benefits:

Improved Quality Control

WHO GMP emphasizes a systematic approach to quality control. It establishes standards for personnel, documentation, sanitation, equipment, materials, and premises. Companies must implement robust processes for sampling, testing, audits, and inspections. This results in more consistent and reliable production quality. Products are less likely to suffer defects, mix-ups, and contamination.

Better Inventory Management

WHO GMP certification requires stringent inventory control and documentation. All materials must be carefully inspected, identified, and accounted for. Strict procedures govern warehousing, including quarantines, storage conditions, stock rotation, and traceability. This improves inventory accuracy and accountability. It also minimizes losses due to expiry, damage, and misplacement.

Increased Transparency

The rigorous record-keeping mandated by WHO GMP makes processes more transparent. Detailed batch documentation provides full traceability for each product. This builds confidence in product quality. It also makes it easier to investigate any issues thoroughly. If an adverse event occurs, root causes can be identified and corrected quickly.

WHO CGMP Requirements

WHO GMP guidelines outline standards and procedures for the manufacturing, testing, and quality control of pharmaceutical products. Some key requirements include:

Quality Management

• Develop and implement a quality management system covering all aspects of production and quality control. This includes procedures, processes, resources, and responsibility assignments.
• Maintain quality control documentation such as specifications, manufacturing formulas, procedures, and records. These should be regularly reviewed and updated.
• Perform quality risk management to proactively identify and mitigate risks to quality.
• Ensure strong change control and deviation management processes. Assess impact and obtain approvals prior to changes. Document and investigate deviations.
• Conduct regular quality audits and self-inspections against WHO GMP requirements. Develop action plans to address findings.

Personnel

• Ensure adequate staffing of qualified personnel in management, production, quality control, and other relevant areas.
• Provide initial and ongoing training to personnel on hygiene, GMP, technical operations, and other topics relevant to their role. Maintain training records.
• Clearly define responsibility assignments and reporting structures.

Sanitation

• Design facilities and equipment to enable cleaning and maintenance to avoid contamination.
• Establish sanitation, maintenance, and hygiene procedures. Monitor and record environmental conditions.
• Ensure proper personal hygiene practices among staff such as use of protective clothing, hand washing, health checks, etc.

Validation

• Validate production processes, cleaning methods, analytical test methods, computerized systems and any other processes that impact product quality.
• Perform re-validation at defined intervals and whenever changes are made that could impact validated status.
• Document validation protocols, results, and conclusions. Include acceptance criteria.

The Certification Process

Obtaining WHO CGMP certification involves a rigorous process to verify that a manufacturing facility meets the high quality standards established by the WHO. Below are the key steps in the certification process:

Application

The process begins with the manufacturer submitting an application and documentation about their quality management system to the WHO. This includes detailed information on the company’s organizational structure, management responsibilities, manufacturing processes, quality control procedures, personnel qualifications, and other factors that demonstrate adherence to CGMP requirements.  

The application must provide evidence that the facility has established and implemented a pharma quality system that conforms with WHO guidelines. All relevant procedures and records must be submitted for review.

Document Review

Once the application is received, WHO reviewers will thoroughly examine the documentation to ensure it is complete and provides adequate evidence of CGMP compliance. This involves checking that the quality system, standard operating procedures, process controls, and other elements fully meet WHO standards.

If any required information is missing or insufficient, the WHO will request additional documentation from the manufacturer before proceeding. A detailed document review verifies the facility’s quality system is robust on paper.

On-Site Inspection

After the documentation is found satisfactory, the WHO will schedule an on-site inspection of the manufacturing facility. The inspection is conducted by a team of qualified WHO GMP experts, usually lasting around 3-5 days. 

The inspection team examines if the actual practices at the facility match what is described in the documentation. This includes observing manufacturing operations, quality control measures, sanitation procedures, record keeping, equipment maintenance, and other areas.

Deficiencies found during inspection will need to be addressed through corrective actions for certification to be awarded. The manufacturer must demonstrate commitment to ongoing compliance.

Granting Certification

If the facility passes the on-site inspection and meets all CGMP requirements to the WHO’s satisfaction, official WHO CGMP certification will be granted. Initially, certification is valid for a 3 year period, after which recertification and re-inspection is required to renew it.

Maintaining rigorous quality standards after certification is essential, as the WHO conducts periodic surveillance audits of certified facilities to verify ongoing compliance. Manufacturers must continue adhering to WHO CGMP principles even after the certification is achieved.

The entire process ensures that WHO CGMP certified manufacturers genuinely fulfill international quality expectations for pharmaceutical production. The result is greater trust in products made at facilities certified by the WHO.

Maintaining Compliance

WHO cGMP certification requires ongoing diligence to maintain compliance. Companies must establish procedures and processes to ensure they continue to meet all WHO cGMP requirements over time. Some key aspects of maintaining compliance include:

Regular Quality Audits

Companies should conduct regular self-audits and inspections of their manufacturing practices, facilities, equipment, documentation, quality control, and more. Internal audits help ensure procedures are being followed properly and identify any gaps that need correction. External audits by independent consultants can provide an unbiased assessment.

Staff Training

All personnel involved in production and quality control must receive thorough training on cGMP principles and the company’s standard operating procedures. Training should be ongoing with refresher courses as needed. Detailed records of all staff training must be maintained.

Documentation

Extensive documentation is required under WHO cGMP, including written procedures for all processes, records of equipment maintenance and calibration, production batch records, product specifications, test results, training logs, audit reports, and more. All documents must be controlled, reviewed, stored securely, and easily retrievable for regulatory inspection.

Adhering to these and other cGMP requirements on an ongoing basis is essential for companies to maintain their WHO certification and ensure consistent product quality over time. A lapse in compliance could put certification at risk.Through rigorous ongoing compliance, companies can build trust in their commitment to quality manufacturing.

Case Studies

India has become a major hub for pharmaceutical manufacturing in recent years. Many Indian drug companies have obtained WHO GMP certification as a mark of quality and to access export markets. Here are some examples of Indian pharma companies with WHO GMP certification and their experiences:

Florencia Healthcare

• Specializes in oncology and generics 
• 90+ oncology drugs including oral solids, injectables and biologics
• Key drugs: Lenalidomide, Thalidomide, Bortezomib, Sorafenib, Tamoxifen 
• Oncology formulations facility in India with capacity of 200 million units per year

Aurobindo Pharma

Aurobindo Pharma is one of the leading generic pharmaceutical companies in India. Its facilities have been approved by regulatory authorities including US FDA, UK MHRA, WHO GMP, among others. Some of Aurobindo’s units certified by WHO GMP include:

• Formulation manufacturing facilities in Hyderabad
• API manufacturing facilities in Hyderabad, Telangana  

Aurobindo has leveraged the WHO GMP certification to export to over 155 countries globally. The certification has helped them meet international quality standards and expanded their reach worldwide.

Lupin

Lupin is the 3rd largest pharmaceutical company in India by revenue. The company’s mandideep facility received WHO GMP certification in 2005. Since then, Lupin has obtained WHO GMP approval for 7 of its manufacturing sites in India. 

For Lupin, the WHO GMP certification has opened doors to enter regulated markets such as the US, Japan and Europe. It has also helped them supply generic drugs to institutional buyers like UNICEF, the Global Fund and other global tenders.

Sun Pharma

Sun Pharma is the largest pharma company in India and a leading generic drug maker worldwide. It has received WHO GMP certification for its facilities in Halol, Toansa, Dadra, Ankleshwar, Panoli and Malanpur.

The WHO GMP tag has enabled Sun Pharma to export pharmaceuticals to well-regulated markets and strengthen its presence in emerging markets. It has provided quality assurance to customers and positioned Sun Pharma as a reliable generic drugs partner worldwide.

Costs of Getting and Maintaining WHO CGMP Certification

Obtaining WHO CGMP certification and maintaining compliance does come with considerable costs for manufacturers. Here are some of the main expenses involved:

Application and Licensing Fees

• Initial application fee – This can range from a few hundred dollars up to $1500+ depending on the certification body. Annual renewal fees are also required.
• Licensing fees – Once certified, manufacturers have to pay an annual fee to maintain their license. This helps fund the independent auditing process. Fees often start around $1000.
• Travel costs – Auditors may need to visit and inspect overseas manufacturing facilities, which adds to the overall certification costs.

Training and Consulting

• Employee training – Workers need proper training on CGMP methods and requirements. Hiring consultants to provide this training costs thousands of dollars.
• Upgrading expertise – Manufacturers may need to bring in expert consultants to overhaul procedures and ensure compliance. Consultant fees quickly add up.

Equipment, Renovations and Documentation

• New equipment – Upgrading manufacturing machinery, software systems and lab equipment to meet CGMP standards requires major capital expenditures.
• Facility renovations – Manufacturing sites may need upgrades to lighting, flooring, HVAC systems, and more to comply. This can mean major construction costs. 
• Documentation – There are extensive documentation requirements. Companies may need new software systems and staff focused on maintaining detailed documentation trails.

As you can see, WHO CGMP certification involves major investments for pharmaceutical companies. However, the benefits of meeting quality standards and accessing new markets often make the costs worthwhile.

Challenges of Obtaining and Maintaining WHO CGMP Certification

Obtaining WHO CGMP certification can be a challenging process for manufacturers. Here are some of the key difficulties companies may face:

• Time and Resource Intensive Process:

Preparing for WHO CGMP certification requires a significant investment of time and resources. Companies need to implement comprehensive quality systems, standard operating procedures, equipment maintenance and calibration programs, document control systems, and staff training. This process can take many months or even years depending on the company’s starting point. Maintaining compliance is also an ongoing effort.

• Regular Audits:

After obtaining initial WHO CGMP certification, companies are subject to regular audits and inspections to ensure continued compliance. This requires diligent preparation and maintenance of facilities and documentation between audit cycles. Any deficiencies must be addressed promptly.

• Updating Standards:

WHO CGMP standards are periodically updated and revised. Companies must keep abreast of changes and update their quality systems accordingly. There are costs associated with implementing new requirements.

• Qualified Personnel:

Following WHO CGMP standards requires knowledgeable and experienced personnel to oversee quality control, production, laboratory operations, equipment calibration, document control, and other areas. Recruiting and retaining qualified personnel can be challenging.

• Significant Costs:

Between infrastructure upgrades, new equipment, documentation systems, increased testing, and additional personnel, WHO CGMP certification necessitates major investments. This financial burden can be prohibitive for some organizations.

WHO CGMP certification brings many benefits for drug quality and patient safety. However, obtaining and maintaining compliance is a serious commitment requiring extensive resources and diligence. Companies must strategically evaluate if they are ready and able to implement the necessary quality systems. With proper planning and execution, the challenges of WHO CGMP certification can be effectively managed.

Conclusion

WHO CGMP certification demonstrates a pharmaceutical company’s commitment to the highest standards of quality, safety, and efficacy for its products and processes. As the pharmaceutical industry grows globally, WHO CGMP compliance is becoming increasingly important for companies that want to supply medicines internationally. 

The requirements ensure robust quality management, qualification of personnel, validated processes, proper testing, complete traceability, and more. While obtaining and maintaining certification requires investment, the long-term benefits for business growth and public health outcomes make it worthwhile. Companies certified by WHO show regulators, business partners, and patients that they adhere to excellence.

Looking ahead, we can expect CGMP guidelines to continue evolving with scientific advances, new technologies, and changing regulations worldwide. Pharmaceutical companies that embrace WHO standards signal their dedication to continuous improvement in GMPs. With globalization expanding access to healthcare, WHO CGMP certification will only increase in importance for manufacturers aspiring to tap international markets. Companies that obtain and uphold WHO GMP conformance can position themselves as premier suppliers known for safety, quality, and ethical practices. As the industry aims to serve growing populations, WHO GMP compliance will remain a vital benchmark for life-saving medicines worldwide.