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How do you find GMP guidance?

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If you work in the pharmaceutical, biotechnology, or medical device industry, you need to follow Good Manufacturing Practice (GMP) to ensure the quality, safety, and efficacy of your products. GMP is a set of principles and guidelines that cover all aspects of the production process, from design and development to testing and distribution. But how do you find GMP guidance that is relevant to your specific product, market, and regulatory requirements? Here are some tips to help you navigate the complex and dynamic world of GMP.

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Eddie Tan, PhD, CABP

Regulatory Scientist | Bridging the gap between Science and Healthcare | Certified Advanced Biotherapies Professional
Véronique Dagois

??J’accompagne les responsables qualité pour l'implémentation des aspects réglementaires | Data Integrity | Validation…
Kieran Falvey, PMP

cGMP Compliance & Contamination Control, Simplified!

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1 Identify your product type

Different types of products may have different GMP standards and expectations, depending on their nature, complexity, and intended use. For example, GMP for sterile injectables may differ from GMP for oral tablets, or GMP for medical devices may differ from GMP for biologics. Therefore, the first step to find GMP guidance is to identify your product type and its classification according to the applicable regulatory authorities.

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Eddie Tan, PhD, CABP

Regulatory Scientist | Bridging the gap between Science and Healthcare | Certified Advanced Biotherapies Professional
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The first step may be to look at your national authority that regulates the particular product type. There could be a national published guidance for the particular type, with references to specific local regulations.

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Véronique Dagois

??J’accompagne les responsables qualité pour l'implémentation des aspects réglementaires | Data Integrity | Validation de systèmes informatisés |
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Elles s’appliquent aux médicaments destinés aux humains ou vétérinaire. Des textes similaires existent pour les produits cosmétiques, et de nombreux secteurs industriels. elles constituent un référentiel réglementaire opposable lors des inspections des établissements pharmaceutiques par leurs autorités de tutelle.

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2 Check the relevant regulations

Once you know your product type and classification, you need to check the relevant regulations that apply to your product and market. Different countries and regions may have different GMP regulations and expectations, and you need to comply with them if you want to sell your product in those markets. For example, GMP for the European Union (EU) is regulated by the European Medicines Agency (EMA), GMP for the United States (US) is regulated by the Food and Drug Administration (FDA), and GMP for Japan is regulated by the Pharmaceuticals and Medical Devices Agency (PMDA). You can find these regulations on the official websites of these agencies or through online databases such as EudraLex or FDA Code of Federal Regulations.

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Véronique Dagois

??J’accompagne les responsables qualité pour l'implémentation des aspects réglementaires | Data Integrity | Validation de systèmes informatisés |
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Les bonnes pratiques de Fabrication sont un ensemble de mesures, de procédés et de moyens d'organisation dont l'objectif est de garantir la qualité et la sécurité d’un médicament.

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3 Consult the relevant guidelines

In addition to the regulations, you may also need to consult the relevant guidelines that provide more detailed and specific guidance on how to implement GMP in your production process. These guidelines may be issued by the regulatory authorities, industry associations, or international organizations. For example, some of the most widely used GMP guidelines are the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guidelines, and the World Health Organization (WHO) guidelines. You can find these guidelines on the official websites of these organizations or through online databases such as ICH eCTD or WHO Technical Report Series.

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4 Seek expert advice

Finally, if you have any doubts or questions about how to find or apply GMP guidance, you may want to seek expert advice from qualified professionals who have experience and knowledge in GMP. These experts may be internal or external consultants, auditors, trainers, or mentors who can help you understand and interpret the GMP principles and guidelines, as well as provide you with practical tips and best practices. You can find these experts through online platforms such as LinkedIn or Upwork, or through referrals from your colleagues or peers.

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Eddie Tan, PhD, CABP

Regulatory Scientist | Bridging the gap between Science and Healthcare | Certified Advanced Biotherapies Professional
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If you are aware of the particular government agency regulating the product type, you may be able to write in to their query emails for a check. These days, regulatory agencies like FDA, EMA, PMDA are open to early consultation to help facilitate product development.

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5 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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Kieran Falvey, PMP

cGMP Compliance & Contamination Control, Simplified!
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Apart from the FDA and EU websites, other industry bodies can be a great source of GMP information. In particular the ISPE and PDA are invaluable resources.

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How do you find GMP guidance?

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1 Identify your product type

2 Check the relevant regulations

3 Consult the relevant guidelines

4 Seek expert advice

5 Here’s what else to consider

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