An Introduction to Manufacturing APIs (Medically Active Substances)
  • CODE : MADE-0002
  • Duration : 60 Minutes
  • Level : Beginner
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Madeleine S. Fairweather Ph.D., MRSB, is a freelance cGMP Course Writer and Presenter. Her background is senior management in Quality Assurance of biological and botanical APIs. She was trained through BARQA (now the RQA), and Pharma Systems International UK Limited, working as a course author and tutor for RQA.  She has specialist knowledge of therapeutic antibodies, blood and plasma, as well as recombinant DNA vaccines, siRNAs and materials requiring special handling gained through 20 years in the industry.  She has been involved in sterile manufacture, technology transfer and ongoing auditing of API suppliers which has taken her throughout Europe, USA, Australasia, and Asia. She has successfully ensured the manufacturing quality of active substances as well as final products and investigational medicinal products (IMPs/INDs) as GMP Auditor, having trained as a Pharmaceutical Lead Auditor through JEMO Limited. She and has successfully guided sponsors and suppliers in achieving licenses for global markets. Madeleine also provides specialist advice and expertise on requirements for importation testing.

The topic is for all those with an interest in the rules and requirements for the manufacture of medically active substances for use as starting materials in the manufacture of human or animal medicines. We look at the development and manufacture of chemical, biotechnological and biological components of drug substances. The basis of the criteria to be met to release material for shipping and downstream processing are discussed.

Current Good Manufacturing Practice (cGMP)

21 CFR 210-211, EU GMP Part II

The manufacture of medically active substances (active pharmaceutical ingredients, or APIs), whether these are chemical,  biological, or plant-based, has to meet defined criteria and purity standards as well as be free from particulate contamination, microbes, viruses, other pathogens and toxins if they are to be used as pharmaceutical ingredients in medicines. The tutor will take you through the regulations and factors which should be considered when setting up and establishing active substance manufacture, including how to select the source material and establish the supply, as well as the steps to go through when designing and establishing the manufacturing process. The criteria for shipping and release for further processing, for use in licensed or investigational medicinal products, are also considered.

Areas Covered

  • Understand and apply the global GMP requirements for selecting and processing active substances
  • Understand the principles behind quality management
  • Be able to use a quality risk management approach to ensure the quality of the active substance
  • Apply the appropriate level of GMP to the stage of API / excipient manufacture
  • Appreciate the responsibilities of the quality unit(s)
  • Appreciate the responsibilities of production
  • Understand the need for production plans (schedules)
  • Understand the difference between master production instructions, batch production records, and laboratory control records
  • Have a concept of materials management
  • Understand product quality control and in-process testing
  • Be able to locate further information on process validation
  • Have an awareness of packaging and labeling;
  • Understand the factors involved in the storage and distribution of APIs
  • Understand the general requirements for audit
  • Be able to locate the rules for particular types of API, e.g., from cell culture/fermentation and other sources
  • Be aware of the controls for APIs used in investigational medicinal products (IMPs) compared to licensed drugs

Course Level - Basic

Who Should Attend  

Everyone involved in good manufacturing practice (GMP) and the quality control and manufacture of active substances for use in pharmaceuticals for human or animal use:

  • Quality and compliance professionals
  • Production personnel
  • Production engineers
  • Quality control specialists
  • Document control specialists
  • Sponsors and stakeholders
  • Senior quality managers
  • Senior technical specialists
  • Subject matter experts
  • Project managers
  • Quality auditors
  • Process owners
  • Distribution specialists

Why Should Attend

Update on FDA 21 CFR 210-211, EU GMP Part II, and ICH Q7 and Q11 on the development and manufacture of chemical, biotechnological and biological components of drug substances. The basis of the criteria to be met so as to release such material for shipping and further processing are discussed.

  • $179.00



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