Transitioning from GMP (Good Manufacturing Practices) to WHO-GMP (World Health Organization Good Manufacturing Practices)

It is a critical leap in the pharmaceutical industry that involves a series of detailed upgrades in the company’s manufacturing, quality control, and operational protocols. This process not only reflects a commitment to quality but also enhances the company’s standing in the global market.

Key Differences Between GMP and WHO-GMP

Scope and Standards:

GMP: A basic certification that ensures that a company's manufacturing processes comply with standard quality and safety practices.

WHO-GMP: This certification is a more stringent, globally recognised system that aligns with international regulatory frameworks. It focuses on meeting the safety, efficacy, and quality standards recognised worldwide by health authorities and regulatory bodies.

Documentation and Record-Keeping:

WHO-GMP demands meticulous documentation at every stage of production, including raw material sourcing, in-process checks, and final product quality. It emphasises:

a)Comprehensive Standard Operating Procedures (SOPs).

b)Extensive batch manufacturing records.

c)Regular updating and control of documents.

d)Traceability of every ingredient and process in manufacturing.

Validation and Qualification:

1)Process Validation: WHO-GMP requires that every step of the production process is validated, meaning it consistently produces results meeting the desired specifications.

2)Equipment Qualification: All equipment used in manufacturing, cleaning, and maintenance must undergo rigorous qualification processes to ensure consistency in product quality.

3)Cleaning Validation: Effective cleaning protocols need to be validated to prevent contamination between different product batches, a key aspect for multi-product manufacturing plants.

Quality Assurance and Control:

Under WHO-GMP, the Quality Assurance (QA) department takes on an expanded role. It must ensure that quality is built into the product at every stage, not just tested at the end.Quality Control (QC) needs to be more robust, focusing not only on end-product testing but also on in-process quality checks and environmental controls.

Facility Design and Infrastructure:

A WHO-GMP certified facility must be designed to minimise the risk of contamination, errors, and mix-ups.

The Key aspects include:

a)Clean Room Design: Controlled environments with strict air filtration systems (HEPA filters), temperature, and humidity controls.

b)Water Systems: WHO-GMP necessitates purified water and steam systems that meet international standards for pharmaceutical production.

c)Flow of Materials and Personnel: There must be strict separation of areas for raw materials, production, packaging, and finished products to avoid cross-contamination.

Personnel Training:

Employees working under WHO-GMP guidelines must be extensively trained not just in their specific roles but in understanding the importance of hygiene, documentation, equipment operation, and adherence to SOPs. Regular refresher training is mandatory.

Sterility and Microbiological Controls:

For sterile products, WHO-GMP emphasises stringent sterility controls during manufacturing, packaging, and storage.

Environmental monitoring for microbiological contamination must be conducted, and limits should align with international standards.

Risk Management:

WHO-GMP mandates the implementation of a Risk Management System. It ensures that risks related to product quality, safety, and efficacy are identified, assessed, and mitigated at every stage of manufacturing. This involves conducting risk assessments regularly and implementing corrective and preventive actions (CAPA).

Audit and Self-Inspection:

WHO-GMP involves frequent internal audits and third-party inspections to ensure continuous compliance.Companies must establish a system of self-inspection, covering every aspect of the manufacturing process, to identify potential gaps and areas for improvement.

Stability Testing:

WHO-GMP requires rigorous stability testing to ensure that products meet the required quality over time. This includes storing products under different temperature and humidity conditions to verify their shelf-life and effectiveness until the expiration date.

Supplier Qualification and Material Control:

Supplier audits must be conducted regularly to ensure that raw materials meet WHO-GMP standards. Suppliers need to be qualified, and every batch of incoming material must undergo stringent testing before being approved for use in production.

Handling of Complaints and Recalls:

WHO-GMP emphasises robust procedures for dealing with complaints and product recalls. It requires a system for recording, investigating, and resolving complaints efficiently. It also mandates having a recall procedure in place to ensure that substandard products are withdrawn from the market quickly and effectively.

Relevance to Consumers

For consumers, the shift from GMP to WHO-GMP certification directly translates to enhanced product safety, efficacy, and reliability. Key benefits include:

a)Global Standard of Quality: WHO-GMP certified products conform to international health and safety standards, assuring consumers that they are receiving a high-quality product.

b)Consistent Therapeutic Results: Since the manufacturing processes are tightly controlled, consumers can trust the consistency in potency, dosage, and overall therapeutic effectiveness across all batches.

c)Minimised Risk of Contamination or Defects: With strict validation of processes and controls, the likelihood of contamination or manufacturing errors is significantly reduced, protecting consumer health.

d)Traceability and Transparency: WHO-GMP ensures that all stages of production, including raw materials, processes, and personnel involvement, are documented, offering transparency and traceability in case of any adverse events or quality concerns.

Increased Trust in the Brand: For the consumer, WHO-GMP certification represents a commitment to excellence and builds trust, especially in markets where counterfeit or low-quality products may circulate.

The journey from GMP to WHO-GMP is a comprehensive overhaul of systems, infrastructure, and quality management. For a company, it signifies the pursuit of the highest standards of pharmaceutical production, which allows access to international markets and broadens business opportunities. For consumers, it brings peace of mind, knowing that the medicines they use are manufactured to the highest global standards, ensuring safety, consistency, and effectiveness in every dose.

This upgrade is not just a certification; it is a testament to a company’s dedication to excellence, patient safety, and global leadership in the pharmaceutical industry.

Regards,

Amit Katoch,

JAKSTAR PHARMA.