Here comes quality and safety first in all most all the industries of today’s world. Especially, quality is urged in pharma industry. Health is the prime concern for every one of us. Times are rapidly changing and getting updated every day with the new technologies coming into existence, bringing new challenges into all the areas. The pharmaceutical industry is into the drug discovery, development, production and marketing of pharmaceutical drugs. In the view of health, medicine is the basic need for the mankind. Hence for health concern and safe consumption of medicines, regulation of the Pharma industry is must and inevitable. For years, Pharma industry has been struggling with quality issues, high product failure rates and regulatory problems. It’s always a high time for the industry to regularize the quality aspects to develop safe and effective drug products. Also, regulatory agencies need to change their effective approach for the drug development, approval, commercialization and manufacturing drug products. The central issue is also a matter of high pricing of medicines in current days. The pharmaceutical industry has a major challenge of patient-centricity. To overcome the challenges and problems in the pharmaceutical industry, several guidelines came into the rule.
India is well known for its largest supplier of medical drugs globally and hence enjoys a key position across the globe having potential researchers and scientists. Indian pharmaceutical sector is the provider of almost 50 percent of global demand for various vaccines and anaesthetics, around 40 per cent of generic demand in the US and 25 per cent in UK. In the current scenario, Medicine usage and demand for drug supply in India is projected to grow over 9-12 per cent for the next five years, thereby leading India to become one of the top 10 countries in terms of medicine consumption. In the view of rising health concerns and diseases and chronic therapies for cardiovascular diseases, diabetic complications, cancers, etc., a better growth in domestic sales would be solely dependent on the ability of companies to align their product services. The Indian government has taken various steps for reaching health to all the needy like bringing generics drug supply into the market, reducing life savings drugs, vaccines costs and bring down the healthcare expenses to aid the needy and also health care programmes and campaigns.
In India, Pharma Knowledge Centre (PKC) is contributing to the best training and guidance, fulfilling the wide knowledge gap between Academia and Industry in making upcoming younger generation/students “Industry Ready” for Pharmaceutical Companies, Bio-pharmaceutical and Clinical Research Organizations. This platform can serve the needs of many students who wanted to land best in their career.
Why only PKC:
PKC is providing customized services to the students with regards to career growth in terms of quality consulting, Job training, Regulatory Compliance (GMP & global regulatory guidelines) and quality management/assurance for Pharmaceutical, Biopharmaceutical, Food industries, Medical device, Biotechnology and FMCG companies. PKC is unique in its training with the best provisions such as:
- Learn and proper guidance from Industry Experienced Experts and certified trainers
- Teaching Mode: Interactive Smart Classroom with German Technology
- Classroom Sessions: Industry ready classrooms
- Best Placement assistance
- Around the corner Enquiry assistance
- ISO Certified (ISO 9001)
- Wide range of GMP Consultancy Customers
- Trending and on demand training courses
- Workshops on various fields
- Advisory Council
India has established a strong domestic pharmaceutical industry with a network of almost 3000 drug companies and about 10,500 pharmaceutical manufacturing units, put of which 1,400 units are World Health Organization (WHO) good manufacturing practice (GMP) approved, 1,105 companies are with Europe’s certificate of suitability (CEPs), more than 950 match therapeutic goods administration (TGA) guidelines and 584 sites are approved by the regulatory agency US Food and Drug Administration (USFDA). The pharmaceutical hubs offer wide investment opportunities in the production of active pharmaceutical ingredients (API) or bulk drugs, biosimilars, vaccines, nutraceuticals and food products. Indian pharmaceutical companies produce around 80 percent of antiretroviral drugs worldwide to fight Acquired Immuno Deficiency Syndrome (AIDS).
Good Manufacturing Practices:
Good Manufacturing Practice (GMP) is a qualitative system for ensuring that products are consistently produced and controlled as per the required quality standards for health, safety and efficacy. GMP is specially brought into force and well designed to minimize the potential risks involved in any pharmaceutical production that intends to harm the patients, environment and cannot be eliminated through testing the final outcome. GMP is followed in every step from raw material to production of desired drugs. GMP in simple focuses on five key elements, which are often termed as the 5 P’s of GMP—people, premises, processes, products and procedures or paperwork. When all five elements are fulfilled, GMP is compliance is satisfactorily completed for the drug production. For Indian pharma, Schedule M describes the quality aspects like quality assurance, self-inspection, and quality control system requirements, listing the requirements for the premises, materials, plant and equipment.
GMPs are more essential into the manufacturing practices for achieving the high-quality products for satisfying the customers. There would be a varied requirement in terms of manufacturing processes for various products. Hence the good in GMPs within the context of the manufacturing multiple food and drug products need to be strictly followed. GMP provides all the exclusive and well-designed guidelines for the processes in the pharma industries.
A need for AMPs (Appropriate Manufacturing Practices), an equally more important and alternative to GMPs are required to be refined based on the clear-cut fulfilment of the desired product and its manufacturing processes. AMPs require justifying the essential process requirements as there would be multiple routes in product quality achievement. Building AMPs facilitates the opportunities for amending the sequence of process, people, facility and infrastructure practices that are used to achieve high product quality. AMPs are in compliance with that of GMP but can also initiate novel methodological approaches crucially important in solving the potential challenges into existence through advanced technologies with regard to the prospective optimization of various process, facility and infrastructure configurations.
Why do Pharma Industry need AMPs?
With the entry of AMPs would not only serve the higher product quality specifications, but also pharma industries would be in alignment with the regulatory bodies and most importantly FDA. There is a strong need for the industries to improvise their approach and methods in drug manufacturing. In view of the pharma industries and the systems followed critical quality attributes need to be driven with the more advanced and sophisticated developmental approaches for the quality performance and output.
Advanced tools and qualitative approaches like quality by design (QbD) and ICH Q8 Design Space are into force. For the higher rates of successful commercialization which in turn yields better quality products, Pharma sector needs a better emphasis on life cycle integration of information and knowledge from the medical or scientific research through commercial manufacturing for the development of AMPs.
Pharma industry must be furious to spotlight the effective modes of quality risk management and assessment and work on the development of QRM methods. Risk management is the crucial aspect in the pharma industry and currently, the approaches in ICH Q9 – QRM like failure mode and effect analysis (FMEA) and hazard analysis at critical control points (HACCP) details the methods for structuring risks, however there is no proper mechanism in assessing uncertainty of the risks, leading to the unintended use of the costly and inefficient precautionary principle (the most notable saying better safe than sorry), resulting in suboptimal risk management.
With the evolution of AMPs into Pharma, there would be a high chance for the opportunities in the modernization of manufacturing processes and facilities that are highly capacity-efficient which enables rapid access to flexible manufacturing assets and thus granting towards much faster cum more efficient product development. Advancement in strong quality management systems, establishing robust operating procedures through advanced facility designs can also expedite less regulatory approvals and supports quality continuous manufacturing.
Major Industry’s Challenge
Pharmaceutical industry is highly facing major challenges in terms of drug development, product failures, clinical trial quality, quality issues and patent issues for long time. In view of the challenges, Indian pharma industry is losing potential ability to develop new products, but it strongly suggests that the pharma industry as a whole needs to alter the methodological approach towards developing new drugs, drug approvals, commercialization and manufacturing of new drug products. Indian pharma claims the challenges like: Pricing of patented drugs, control of drug pricing by government (To ensure that high-quality generic medicines reach needy patients at most affordable price), fake drug products, lack of skilled man force, and dependant on China for raw materials.
Pharma digitalization will bring about major difference in approach and industry will observe sustainable growth opportunities in next decade. The way forward, Pharma industry need to strive for the nation’s quality healthcare. Also, regulatory policies need be improved, mainly in the area of patent and price control, to boost the pharma growth for the newer generation pharmaceutical market.
The FDA’s Challenge for Pharma Industry:
FDA is one of major regulatory body inspecting pharma industries to be more focused on developing practices for its drug products and manufacturing processes complying with cGMP. The systematic approach would always force the drug industry to identify product requirement, developmental methods, and implementing practice-based control systems necessary to satisfy GMP requirements. Many of the Indian manufacturing facilities struggle to maintain proper documentation (data integrity) of testing and sample data. “The USFDA has also been increasingly issuing warning letters to the Indian companies, denying any GMP compliance. In the recent times, FDA announced carcinogenic impurities identified Ranitidine products.
Can Pharma manufacturers really afford to implement AMPs?
Many pharmaceutical manufacturers are already in line with cGMPs that implement comprehensive, modern quality systems and risk management approaches. Today’s pharma world is all moving around the fashionable motto of being patient-focused, as patient is the ultimate end user of life saving drug products. Manufacturing poor quality products does not serve the real essence of Pharma industry in saving lives and it’s just a money waste process. Poor quality drugs also disturb community health and leads to loss of credibility for everyone. Also, in the long run it would create a havoc and expensive deal in finding out the errors or root cause for eradicating recurrence. GMP is more prominently designed to ensure that no mistakes occur in drug manufacturing. Investing in GMP implementation adds value to the pharma industry and thereby produces good quality medicines. This will further aid in improving the health of the individual patient and the community, as well as commercially benefiting the pharmaceutical industry. AMPs would bring about a considerable change by reimagining the current regulatory approaches and making industry fully responsible for all the practices. Also, the industry will rise to the challenge and eliminate all the obvious and incompetent compliance errors mostly found in FDA inspections.
AMPs, just like GMPs would bring about greater and prospective resolutions to many of the complex issues faced by Pharma industries. However, AMPs implementation would pose an extra burden to the industry in its problem-solving approach. Aligning with the FDA is also a tougher job for the Pharma industries. For a shift or movement from the existing GMPs to AMPs will certainly require better approaches for interacting between the agency and industry. Also the novel transformation would require the regulatory body – FDA to collectively and aggressively join to work on par with pharma industry to learn and understand the appropriate practices defined/followed by the industry to achieve the production of high product quality with appropriate practice-based controls required. Both industry and FDA can work together using FDA’s Voluntary Consensus Standards (VCS) to analyse better approaches for efficiently managing product life cycles in high gear and rewardingly bring new therapies to serve the patient community in need.
- The future of pharmaceutical quality and the path to get there. https://europepmc.org/article/med/28619448
Pharma Knowledge Centre – “My Learning Life” (PKC) engaged Young Indian Youths to prepare this presentation/Blog and the same has been prepared by one of the associated youngsters in consultation with PKC.
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