Pharma GxP for Beginners

GxP is a set of rules that are required for the safety and quality of pharmaceutical products.

In the pharmaceutical sector, the "x" denotes the following areas:

• Manufacturing

• Distribution

• Laboratory

• Clinical

• Documentation

In this guide, we discuss the GxP basics in the pharmaceutical sector, according to each "x" value and the set standards by different regulatory bodies in the world.

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Good Manufacturing Practices (GMP)

GMP is a management system for consistently manufacturing and managing products per quality standards. The system mitigates the hazards inherent in any pharmaceutical manufacturing process that you cannot remove through final product testing. Agencies that regulate the certification and licensing of food and drinks, cosmetics, pharmaceuticals, food supplements, medical equipment, and other products set these standards.

The GMP requirements encompass all elements of manufacturing, from raw materials, facilities, and equipment to employee training and personal cleanliness. Regulatory authorities in the U.S., China, Canada, Europe, and other nations monitor manufacturing procedures and acceptable clinical and laboratory practices.

• EU Good Manufacturing Practice (GMP) Guidelines, Volume 4

• US FDA current Good Manufacturing Practice (cGMP) guidelines: 21 CFR Part 11, 210, 211, and 820

• WHO Good Manufacturing Practices for pharmaceutical products, Annex 4 to WHO Technical Report Series, No. 908, 2003

Risk Management Requirements

USP provides risk management practices for companies handling distribution. It outlines how companies should structure their procedures to account for risk factors such as:

• The pharmaceuticals they distribute
• The supply chain's number of steps and receipts
• Manufacturers' specified storage instructions
• Medications at danger of freezing or exposure to extreme temperatures (e.g., insulin, vaccines, and biological products)

USP guidelines emphasize the need for formal quality management systems (QMS) to define and implement the controls for achieving basic GxP requirements, reducing product failure risks. The QMS serves as a central source for the documented policies and procedures necessary to preserve the product's safety, integrity, and effectiveness through manufacturing and the supply chain.

The QMS is an updatable, authoritative source for best practices and a training resource for industries to understand and implement set standards. It also requires logging and recording protocol violations which initiates remedial actions, documentation, and evaluation. QMS manages all records and data, making them accessible to regulatory authorities upon request.

Good Distribution Practices (GDP)

GDP refers to the minimum guidelines wholesale distributors must adhere to for the continued integrity and quality of pharmaceutical products across the supply chain.

Each nation's rules and regulations are unique, involving a domestic or international body like the FDA in the US, the European Commission in Europe, or Swissmedic in Switzerland 

Along with formal rules, several organizations publish guidance documents explaining and supporting the requirements in distribution and their use in particular circumstances.

They include the following:

• International Society for Pharmaceutical Engineering (ISPE)

• Parental Drug Association (PDA)

• Occupational Safety and Health Administration (OSHA)

• World Health Organization (WHO)

Thus, the GxP basics are dynamic and evolve by the day with new regulations and the publication of new guidance materials. The European Commission has adopted Directives 2001/83/EC and 2001/82/EC for GDP and GMP recommendations. Manufacturers in the European Union use the European Pharmacopoeia as a guide.

IATA, the CEIV Pharma Program, and the TCR

The International Air Transport Association (IATA) acknowledges that the pharmaceutical sector makes every effort to avoid air transportation for sensitive products. Turbines generate heat in the plane, delays leave cargo vulnerable to temperatures outside of the plane, and product transfers from airport to ground transportation can take weeks. Nearly 80% of all reported global pharma temperature excursions occurred by air transport. As a result, IATA established the Time and Temperature Working Group (TTWG) to develop the Temperature Control Regulations (TCR). This guide assists in handling and transporting temperature-sensitive merchandise to meet drug-industry specifications. IATA's guidelines increased industry-wide awareness of these problems and pioneered the Time & Temperature Sensitive (TTS) label still in use today.

Unfortunately, IATA realized that a label alone was insufficient and established the Center of Excellence for Independent Validators in Pharmaceutical Logistics (CEIV Pharma). The CEIV Pharma program assists air cargo logistics in attaining pharmaceutical handling efficiency and enhancing security, safety, compliance, and overall performance. Certification of airports, trading lanes, providers, and whole infrastructures is now possible via staff training, equipment upgrades, and the implementation of checklists or procedures.

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From a pharmaceutical supply chain viewpoint, the regulatory framework's foundations are the GMP and GDP standards, often referred to together as the GxP basics. In general, GMP focuses on manufacturing operations, including testing and monitoring, dispatch, and warehousing. On the other hand, GDP deals with pharmaceuticals' transportation, including conveyance, storage, and wholesale. Both GMP and GDP aim to promote public health by guaranteeing product quality.

Good Laboratory Practices (GLP)

GLP is a system of guidelines that controls the quality and dependability of non-clinical laboratory research in government investigations or marketing clearances. In the pharmaceutical industry, GLP refers to the non-clinical animal testing required before the approval of new medicines. In addition, GLP covers color and food additives, medical equipment, and food contamination limits and packaging.

Research directors are responsible for overseeing and executing all elements of the non-clinical research. Directors are essential for the successful implementation of best practices in a laboratory.

GLP is found in The European Commission Directive for GLP is 2004/9/EC and 2004/10/EC. It can also be found in 21 CFR Part 58 since it is a management quality control method that regulates non-clinical environmental investigations.

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Good Clinical Practices (GCP)

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation, is an organization of regulatory authorities within the industry to develop guidelines to be used internationally. They establish GCP guidelines for clinical research, which countries may then convert into legislation.

GCP is an international standard that regulates aspects of science-based and ethical clinical trials, covering:

• Design
• Conduct
• Performance
• Monitoring
• Auditing
• Recording
• Analyses
• Reporting

Good Documentation Practices (GDP)

GDP is also known as GDP 21 CFR Part 11 or GDocP. While predicate principles were originally applicable to paper documents needing handwriting and signatures, they remain in force even in the presence of electronic health records and signatures. The U.S. Food and Drug Administration (FDA) Code of Federal Regulations (CFR) Title 21 Part 11 is now an additional requirement for electronic documents and signatures in the digital space.

Part 11 standards do not supersede or replace the existing FDA, GDP, GCP, GLP, or cGMP rules governing signatures and documentation. Handwritten and e-signatures applied to electronic records must be connected to the corresponding electronic records to prevent the signatures from being removed, duplicated, or otherwise changed to fabricate an electronic document.

EU GMP Annex 11: Computerized Systems

As the use and sophistication of automated processes grow, the EU amended Annex 11 in 2011 to cover all computerized systems used in GMP-related operations. In today's increasingly more digitally linked world, knowing the EU regulations, like Annex 11 and the US FDA's equivalent and 21 CFR Part 11, is more important than ever before.

Conclusion

With this GxP for beginners guide, you can successfully start using the GxP mechanism to prove the quality of your products, ensuring safety for consumers and increasing profits. Experts at ELPRO can help you understand and implement the regulations regarding environmental monitoring in the pharmaceutical industry. This way, you ensure consistency and quality in your processes.