GMP regulations (PIC/S guidelines) for Biologicals manufacturing were covered in the PE009-14 PIC/s (Annex 2: Manufacture of Biological Products for Human Use).
Note: Annex 2 was updated in PIC/s version 15 – to Annex 2A (ATMPs) with Annex 2B covering Biological medicines.
** Note – the new course on Annex 2A (ATMPs) and for Annex 2B (Biologicals) are in development and will be published in July and August 2021.
This blog relates to GMP requirements for biological medicines in PIC/s Version 14.
Ensuring the safety of employees, clinical researchers, vaccination testing employees, hospital workers and the public is increasingly important given the current climate of the rapidly-spreading coronavirus (and COVID-19 outbreaks).
If you haven’t updated your PIC/s GMP training per regulations, ensure you familiarise yourself with your legal and professional requirements per PIC/S guidance for GMP01, GMP02 and relevant Annexes. These include Annex 2 (Manufacturing of Biological Medicines for Human Use) — as well as GMP orientation and newly-updated 2020 courses.
2020 GMP: Annex 2 Biologicals Training Course updated for PE009-14
Manufacturing of biological medicinal products involves unique risks to patients, public health, animals, the environment, and manufacturing/distribution personnel.
Compliance with all relevant GMP regulations and national legislation for biological manufacturing is crucial for ensuring the quality, safety and efficacy of these important medications.
Appropriate GMP compliance training is also compulsory for protecting your biological manufacturing personnel, global public health, and medical supply chains.
Employee/contractor and supplier training: Our online GMP compliance training for Annex 2: Manufacture of Biological Products for Human Use has recently been updated.
Purpose: Our online GMP training course for Annex 2, updated in 2020, aims to help pharmaceutical production teams, biological researchers and supply chain personnel refresh their understandings of basic GMP requirements for biological medicine production. This includes the manufacturing of biological investigational medicinal products (IMPs).
This Annex 2 (Biologicals) GMP training course is an excellent resource for induction training or retraining of pharmaceutical manufacturing employees, laboratory teams, IMP chemists and biological research personnel.
Others who may be helped by this course: vendors/suppliers, contractors/sub-contractors, engineers, hospital employees, data analysts/data integrity teams, and supply chain personnel (e.g., logistics teams, warehouse staff, security teams, and distribution personnel). It may also suit others who need to understand and comply with GMP requirements relating to biological medicines in the workplace.
This GMP Certificate Course is best combined with additional training, to help ensure all relevant GMP guidelines and Annexes are understood, implemented and monitored for compliance with regulations and national legislation.
Our online GMP Annex 02 training, GMP induction and GMP refresher courses should be combined with a comprehensive in-house training program and appropriate QMS/QPM monitoring as per legislation and auditing requirements.
The importance of GMP and Annex 2 (Biologicals) training
Compliance with all relevant regulations and legislation relating to biological medicine manufacturing is crucial to:
- ensure the safety, quality and efficacy of the products
- protect public health outcomes
- provide environmental protections
Working with biological medicinal products includes sourcing of starting materials as well as researching, manufacturing, reprocessing, testing, storing and distributing biological medicinal products and derivatives.
From starting materials to supply chain integrity (storage and distribution processes, serialisation/labelling, etc), biological products must ensure:
- National safety guidelines for pharmaceutical quality management are followed at all stages of production/distribution
- Quality Management Reviews and self-inspections (audits) occur at designated intervals
- Appropriate handling and storage of IMPs, vaccines and other biological products
- WHS regulations for personnel and public safety are followed, including PPE (Personal Protective Equipment) and incident reporting
- Animal care and animal welfare standards are maintained according to National and State legislation
Other regulations and policies impacting biological research, drug testing, clinical trial administration, manufacturing and distribution may also apply.
About our online training courses for PIC/S (GMP) and biological medicines
Biohazards of biological manufacturing including contamination risks
Our newly updated online GMP training course for ANNEX 2 describes the complex nature of researching and/or manufacturing biological pharmaceuticals.
These products include but are not limited to: “virus medications/vaccines, therapeutic serums, anti-venoms, blood-or-plasma derived medicinal products, toxins/antitoxins, allergenic products, and analogous products (derived from living materials).” (Sources: compiled from FDA, TGA and PIC/S Annexes 1-20 resources).
In addition to our online training resources for PIC/S GMP Annex 2 training, additional GMP Certificate Courses (induction training packages) are available.
- Training can be ordered online and accessed (typically accessed immediately upon order).
- Note GMP training prices are listed in US Dollars.
- Each trainee must have an individual log-in (a unique registration).
- Industry bundles offer a discounted GMP training option.
Do trainees get GMP Training Certificates after completing online courses?
- Yes. Certificates of Completion for online GMP training courses can be printed or downloaded after successful completion of the course and course assessment.
- Training certificates and training records of ALL completed GMP training should:
- be kept by the employee completing the course
- provided by employees to HR/QMS Personnel according to organisational policies
- be readily available when undergoing a PICS/GMP audit by authorities (national regulators)
How to use online GMP training courses including for Annex 2 (Biologicals)
Our courses are best used for GMP orientation training for employees, suppliers, contractors, engineers and distribution personnel, including good manufacturing practice refresher courses options.
- These online GMP training packages should be implemented as part of a blended learning solution, adapted to your particular production requirements.
- Our top GMP training related blogs provide additional resources in relation to the training and development of pharmaceutical production personnel.
Other guidelines for biological manufacturing personnel and contractors
Compliance with all parts of regulations, including supplier audits, quality system reviews, self-inspections, GDP/GRK and data integrity, are crucial to batch traceability in the event of adverse incidents and/or recalls.
Other relevant GMP Guidelines and national legislation, must be followed. These include, but are not limited to:
- Annex 1 GMP (sterile medications)
- Other relevant PIC/S Annexes for the manufacturing of medicines, which may include (but are not limited to):
- World Health Organisation (WHO) Annex 2 guidelines for biologicals
- Regulations covering biohazards (including zoonosis risks) and biological waste materials
- Workplace Health & Safety (WHS)
- Zoonosis reporting regulations
- Biohazard incident reporting requirements
- Record-keeping, data integrity, and data retention
A good training program for manufacturing biological medicinal products should include:
- the importance of regulation compliance
- the biohazardous and variable nature of biological medicinal manufacturing, storage and handling
- protection requirements for personnel, public health and the environment (overview)
- fully-traceable batch documentation, e.g., the importance of good recordkeeping, sampling and distribution documentation (covered in individual training modules)
- supplier monitoring/supplier audits and review processes
Of course, your overall training approach must include onsite training and drug-specific training.
Quality management systems, risk assessments, quality review processes, CAPA and other GMP must also be implemented according to GMP and legislation relative to YOUR specific pharmaceutical products.
Annex 02: What are biological medicines?
Biological medicines may have different classifications and hence, varying regulation compliance requirements depending on the product and manufacturing processes, and the regulatory agency.
Biological products are differentiated by the fact they are “produced from living materials”, often in smaller batches than other medications. They are complex in terms of production requirements, quality and safety testing and biohazard risks including contamination/cross-contamination. (Sources: FDA, TGA and PIC/S Annex 2 references).
Examples of biological medicines*:
- vaccines including vaccine products in development re the 2019-2020 corona virus outbreak, currently being investigated for quality, safety and efficiency in relation to COVID-19
- medicines derived from spore-forming microorganisms
- tissue-based products including tissues from donors including organ-donors (e.g., skin, bone, ocular, cardiovascular tissues, amnion)
- cell-based medicinal products (e.g., in vitro cell expansion or depletion; IVF products used to treat infertility)
- immunotherapy products and combination medical therapies
- products that comprise (and/or contain) live animal cells, tissues or organs
- autologous human cells and tissue products (e.g., stem cells, autologous adipose tissues/autologous fat transfer)
- products used for faecal microbiota transplant(FMT); e.g. containing or derived from human stool
- nanomaterials used to enhance the bioavailability of other drug components
References, Resources and Sources:
PICS Guide to Good Manufacturing Practice for Medicinal Products (PIC/S GMP Guidelines and resources)