Governance, Risk and Compliance Blog

Good practice (GxP) in the pharmaceutical industry

Posted by Marc Gardner on Fri, Sep 08, 2017

If your business operates in a heavily regulated industry such as pharmaceuticals, you're likely to know all about the concept of good practice (GxP).

GxP guidelines – the 'x' stands for the particular field, whether that's manufacturing (GMP), distribution (GDP), laboratory (GLP) etc. – were established in the US by the Food and Drug Administration (FDA). They aim to ensure that businesses working in regulated industries make products that are safe and fit for use and have met strict quality standards throughout the entire process of production.

The guidelines are generally similar from country to country, and each country has its own regulator. However, many manufacturers aim to meet the FDA's requirements so they can sell to the US market, which is the world's biggest market and so the most profitable.

The five Ps of GxP

GxP is no different to any other quality standard in that it's often complex to interpret and difficult to put into practice. Frequently, it involves implementing some kind of quality management system. But we can boil GxP down to five main elements – the 'five Ps'.

People
  • Have clear roles and responsibilities
  • Follow all procedures
  • Fully trained and assessed for the work they do
Procedures
  • Documented and recorded
  • Cover all critical processes
  • Ensure deviations are fully investigated
    and reported
Products
  • Specifications for raw materials, components, intermediate and finished product
  • Methods for manufacture and packing, testing, sampling, status control, stability testing and records
Premises and equipment
  • Designed to allow effective cleaning and prevent cross-contamination
  • Validated and calibrated, have procedures, schedules and records
Processes
  • Clearly defined, consistent and documented
  • Critical steps identified
  • Any required changes must follow the change control procedures


GxP and the pharmaceutical industry

Good manufacturing practice (GMP)

Any company that wants to make human medicines needs a manufacturer licence issued by the industry regulator – in the UK, this is the Medicines and Healthcare Products Regulatory Agency (MHRA). MHRA will only issue a licence when the company can show it complies with GMP and passes regular inspections.

When we buy medicines, we have no way to check their quality, and so we trust that they're safe, effective and produced to rigorous standards. Ultimately, GMP sets out best-practice methods for manufacturers to ensure their products are packaged and labelled correctly, are uncontaminated and have the ingredients and strength they claim to have.

Basic overview of the drug development process

The guidelines concern all aspects of production, requiring, for example, that:

  • Facilities are of the proper size and kept in good condition
  • Equipment is properly calibrated and maintained
  • Employees have the appropriate qualifications and training
  • Processes are reliable and consistent
  • The correct materials, containers and labels are used

GMP is just one element of what the EU guidelines call quality management, which, along with quality control and quality risk management, forms part of an overall pharmaceutical quality system. An EU directive makes it mandatory for medicines manufacturers to implement such a system. Done correctly, it lessens the risk of contamination, mix-ups, deviations and errors.

Good distribution practice (GDP)

No person or company can legally sell, supply, import or export human medicines without holding a wholesale distribution authorisation (also known as a wholesale dealer licence). And being issued such authorisation means complying with GDP.

GDP helps distributors navigate an increasingly complex supply chain involving suppliers, factories, warehouses, distribution centres and retailers. The guidelines ensure that a medicine's quality is maintained throughout all stages of the supply chain, from when it's first produced by the manufacturer to when a pharmacy or medical professional provides the product to the public.

The guidelines concern aspects of distribution such as:

  • Purchasing
  • Storage
  • Transportation
  • Repackaging and relabelling
  • Documentation and record-keeping

One major aim of GDP is to protect public health and safety by preventing counterfeit, illegal or substandard medicines from entering onto the market.

Image credit: www.pharmpro.com

Good laboratory practice (GLP)

GLP was devised to promote the development of quality test data, both to help protect human health and the environment and to allow reliable scientific data to be shared between countries.

The guidelines cover the safety testing of items contained in:

  • Medicines
  • Pesticides
  • Cosmetics
  • Veterinary drugs
  • Food additives and feed additives
  • Industrial chemicals

These items could be man-made chemicals, naturally occurring substances or living organisms. The items are tested so data can be gathered on what exactly they contain, and whether they pose any risk to human health and/or the environment.

Wherever the tests are conducted – a laboratory, a greenhouse or out in the field – the facility must meet strict standards in terms of procedures, equipment and personnel. And every study must be planned, performed, monitored, recorded, archived and reported under the proper conditions.

Good clinical practice (GCP)

GCP is an international standard for designing, conducting, recording and reporting clinical trials in which human subjects take part. By complying with the standard, organisations that conduct clinical trials are able to give assurance that they're protecting the subjects' rights, safety and wellbeing, and producing reliable, credible data.

The guidelines specify:

  • Before a clinical trial is set in motion, the possible risks must be measured against the expected benefits. The trial must only go ahead if the benefits outweigh the risks.
  • The trial must be based on sound scientific knowledge and its procedure must have been approved by the relevant review board or ethics committee before the trial proceeds.
  • All personnel involved in conducting a trial should have the proper education, training and experience to perform his or her role. All subjects must have given consent freely and based on full information about what they're consenting to.
  • Any medical care subjects receive must be given by a qualified medical professional.
  • All data should be recorded, handled, and stored in a way that allows it to be accurately reported, interpreted and verified.
  • Any records in which subjects could be identified should be kept confidential.

 

What you should do now

Does your business manufacture medical devices? Download our ISO 13485 toolkit to learn more about the standard and implementing quality management systems.

ISO 13485

Tags: Pharmaceutical Regulation, GAMP

Join us at the Quality Context Training Conference in Sheffield

Posted by Emily Hill on Thu, Sep 24, 2015

Join us on the 20th October at the Showroom Cinema in Sheffield for the first ever annual Quality Context training conference.

Organised by Quality Context, a key Qualsys partner, the conference will bring together thought-leaders in the pharmaceutical and healthcare industry to discuss the future of GMP, GDP, GCP and GPvP.

Here are a few of industry experts who will be speaking at the event:

 

Alexis Krachai, Director of Counter Context, advises some of the world’s largest healthcare companies on strategic positioning, stakeholder consultation and staff engagement. Alex will give a presentation on Communicating the Importance of Quality.

 

Victoria Cavendish, Director of Orca Solutions Ltd, has over 14 years’ experience across academia, health service, Clinical Research Organisations (CRO’s), and the private medical device sector. Victoria will be delving into the details on Delivering Quality in the Medical Device Industry.

 

Derek Woodcock, Associate of Quality Context, is a PV expert, with over 30 years’ regulatory and pharmacovigilance experience in R&D and commercial environments. Derek will give a presenting Developments in ADR Reporting: A Limitation or an Opportunity for GVP Audits.

 

Peter Miles, Consultant and Facilitator at Catalyze, uses software models to help groups with collective sense-making. Peter will be providing us insight into Collaborative Decision-Making: Managing Complexity, Uncertainty & Diverse Perspectives.

 

Ian Birch, Director of BECO Integrated Services Ltd, has a wealth of experience in commercial and clinical roles with technical, quality and auditing experience. Ian will be presenting Mergers, Acquisitons and Sales: The Impact On The Pharmaceutical Quality System.

 

Iain Moore, Global Head of Quality Assurance at Croda International Plc, has helped define and implement GMPs for cosmetic and pharmaceutical ingredients. Ian will discuss Why the Guidelines for Ascertaining GMP for Excipients Are The Best Thing Since ICH Q7.

 

All proceeds for the event will be donated to Children’s Hospital Charity. The event starts at 9am and ends at 6pm. 

To sign up, email enquiries@qualitycontext.com, we look forward to seeing you there.

 

Tags: Events, Pharmaceutical Regulation, ISO 15189

ISPE GAMP Forum increasing dialogue in Pharmaceutical Regulation

Posted by Ben Saxton on Tue, Dec 09, 2014

Qualsys recently attended the International Society for Pharmaceutical Engineering (ISPE) GAMP Forum, an event organised to increase dialogue and practical guidance between those involved in pharmaceutical regulation.

Michael Ord and Ben Saxton both attended the event to further their Pharmaceutical sector knowledge and understand the issues many of our clients face. As a vendor organisation we were pleasantly surprised and grateful of the open culture and welcoming nature of the forum.

Common issues within pharmaceutical compliance were shared with other members of the forum with a shared goal of improving practice for all. The November event was held at the recently opened and incredibly impressive Waters Mass Spectrometry facility in Wilmslow. The facility is an inspiring space to hold a forum and all delegates enjoyed the fine catering provided.

WW

The forum consisted of a number of presentations all delivered by an expert of their field as well as break-out sessions where a number of different topics were debated.

Trevor Simmons of ZigZag started events with a thought-provoking presentation on the use of Cloud solutions. We were all in agreement of the advantages that Cloud could offer but definitions are required around what “Cloud” refers to with Open Clouds, Community Clouds and Private Clouds all available to organisations. Trevor stressed the importance of being aware of the need to control where our data resides, especially if you need to conduct data destruction at any time.

Chris Reid of Integrity Solutions updated the forum on the ISPE special interest groups including mobile apps led by Sion Wyn of Conformity, the result of which is the ISPE GAMP Mobile best practice. This discussion may have been aimed at addressing issues faced by mobile apps designed for the general public more than the corporate world but was still of great interest to ourselves. Our iEQMS Auditor App for the iPad is in general use by a great number of our clients including those who are FDA regulated.

Sion Wyn

John Andrews of Integrity and Heather Wilkinson from GSK hosted an open floor discussion on regulatory intelligence in which the need for electronic signatures, the FDA being able to take pictures on site and audit trail were all raised. We have been developing a complete audit trail solution to live within EQMS for some time and the points raised within this discussion were reassuring to hear from such an audience.

We attended the round table discussion, focussing on how to select a suitable partner organisation when outsourcing key functions, while as a group we exploring how such a critical relationship is measured. It’s hard to give a definite answer for this but a mixture of well-designed metrics and the less quantifiable ‘how well do they deliver this service’ appears to be the best measure.

"It was enlightening to spend the day with Quality professionals from the Pharmaceutical world, sharing ideas and best practice during the round table break-out sessions. As a supplier of an audit manager application currently in place within the pharmaceutical industry, the final presentation on the use of Mobile Apps within the industry was very interesting and has started numerous new product discussions within our organisation."

- Ben Saxton, Qualsys' Business Development Manager

Qualsys value the continous personal development of their staff as well as ensuring EQMS is developed to provide a solution to the challenges faced by both prospective and existing clients alike. The ISPE GAMP forum helped deliver on both of these points. For a more in depth report or to receive a demonstration of the iEQMS Auditor App please contact Ben or Michael on 0114 282 3338

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Tags: EQMS, Events, FDA, Pharmaceutical Regulation, GAMP

‘Obamacare’ shifts global power balance of Pharmaceutical Industry

Posted by Michael Ord on Fri, Oct 18, 2013

As the gridlock in Washington subsides for the time-being, the effects of the Patient Protection and Affordable Care Act; so-called ‘Obamacare’ are set to extend to all corners of the globe.

washington 


Obamacare looks set to trigger a shift in the balance of power in the global pharmaceutical industry. We review the news to identify the key issues for Quality and Compliance Teams within Pharma-chem companies.

$350b Bonanza for Indian and Chinese Pharma

pharma image

The introduction of the new legislation will inevitably lead American purchasers to source generic drugs at a reduced cost. Indian and Chinese generic manufacturers are gearing up for a bonanza that will see them try to prise away market share in the $350 billion US market.

The major challenge for the Indian and Chinese manufacturers will be compliance with exacting FDA regulations and the introduction of compliant manufacturing processes and record keeping essential to deliver the product quality expected by the American market.

FDA Sanctions in 2013

Already this year, according to agency data, as many as 19 manufacturing facilities in India have been barred by the FDA from supplying products to the US, more than any other country. Problems faced by Ranbaxy Laboratories, Wockhardt, RPG Life Sciences and Dabur India have been widely publicised and here. Chinese Pharmaceutical facilities have received the next highest number of sanctions at seven.

Indian and Chinese companies will need to accept intense scrutiny if they want to make the most of the opportunity. India is one of the first countries, apart from China, in which the FDA has opened offices, and the country recently allowed the regulator to increase its number of inspectors in the country by seven to 19.

Conclusions

The US and European pharmaceutical giants will no doubt look to protect their position but this is likely to lead to cost-cutting and pressure on the ability to deliver quality at the right price.

This dilemma of a squeeze in resources and a demand for greater efficiency will force Quality Managers and Compliance Teams to review their processes, adopt new technological approaches all under the burden of greater over-sight.

Ultimately, the consumer is set to benefit provided the FDA and other regulators retain the power and sanctions needed to assure their protection.

Robert Oakley, Qualsys Director said:

"At Qualsys, we are already seeing a greater demand for iEQMS Auditor for mobile auditing, ECMS Change Management software and EQMS Risk Manager - all tools with powerful workflows that can easily demonstrate business efficiencies and ROI. 
 

iEQMS Auditor for iPad

EQMS interest from Pharmaceutical Manufacturers in China, the Middle East and the US, shows us that everyone sees the same opportunity and feels the same pressures.

It will be interesting to see how Obamacare plays out."


 

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Image credit: here and here

Tags: EQMS, FDA, Pharmaceutical Regulation