Are you an experienced trainer, but new to the Pharmaceutical industry and cGMP compliance training programs?
Perhaps you are a business owner – or recently promoted into a Quality Management role – with responsibilities for training new hires and long-term employees?
- If you find yourself leading a Manufacturing Department OR managing the organisation’s regulatory compliance training program, there are 10 essential steps you need to take to ensure your cGMP training program is effective and compliant.
- If you’re already familiar with cGMP training requirements, use this article as a ‘checklist’ to ensure you’re still on track — before your next self-inspection or audit!
Best practice cGMP education programs (Metrics)
Good Manufacturing Practice (GMP) training programs are important for ensuring (1) regulatory compliance and (2) product safety, quality and efficacy. *Note: we’ll refer to GMP rather than cGMP for simplicity from this point forward.
- It’s important to remember that establishing a ‘GMP compliant culture’ is not a one-step mission.
- Compliance cultures are achieved by ensuring the right mix of training, supervision, governance, technologies, resources, and positive reinforcements.
Personnel must also be enabled – and empowered — to “do the right thing” in a regulated environment (for example, reporting a deviation or non-conformance). This means management must ensure personnel and contractors have ALL the resources they need – of which training is only one of them.
- Well-written SOPs and up-to-date work instructions are also pivotal
- Click here for SOPs/quality procedure templates for your PQS or QMS
- Click here for a best-practice technical writing course and SOP writing workshop delivered via Zoom.
- Processes and computer systems must be validated, and validation documentation must be closely monitored, especially as quality control activities can fall behind schedules during personnel absences (so common during the pandemic).
In terms of your GMP education/cGMP compliance training programs, key considerations include:
- All applicable regulations*
- Frequency of training
- Effectiveness of training
*Examples: cGMP, importing/exporting laws, biosecurity considerations, serialisation requirements, waste management, etc.)
Let’s explore 10 key steps you should take to ensure your cGMP compliance training program meets its objectives.
10 key steps to managing a GMP compliance training program
Step 1: Analyse your requirements
Review all applicable GMP regulations and guidance documents
- Running a training program of any kind starts with understanding the requirements.
- Start with a thorough review of all applicable regulations including regional regulations, API/bio-security regulations, and product-specific GMP requirements.
- Be sure to keep updated copies of the regulations on your central system and that employees have access to the regulations as required.
- Fully document the process and make notes of any areas of concern in terms of quality control and non-compliance issues.
- It is helpful to review any warning letters or audit findings related to your organisation OR to other companies in the same region and/or producing similar product types.
What does this step require?
Understanding the requirements of a GMP compliance training program for your employees, contractors, CMOs and other vendors/suppliers requires you to analyse:
- The product/s being manufactured and API requirements (as in PIC/S GMP Part 2)
- Active Pharmaceutical Ingredients (APIs) specific to your product (e.g. covered in PIC/S Annexes)
- GMP compliance guidelines relevant to those products such as:
- PIC/S GMP Guidelines Part I and II
- PIC/S GMP Annexes specific to your product types
- Region-specific guidance publications (e.g., FDA’s CFRs 210-211 and CFRs 800-820) or the TGA’s TGO93 guidelines
- Regional guidance for every country/region in which your products are being supplied
- ISPE technical guidelines and engineering requirements
- Pharmacovigilance, deviations and non-conformance management, CAPAs, and complaint management systems (including Adverse Event reporting requirements for your region)
- The risk classification of your products and/or active pharmaceutical ingredients (APIs) in the regions you’ll be audited
- The use of overseas suppliers (supplier qualification processes)
- Validation and qualification compliance requirements (e.g. cleaning validation requirements)
It is very helpful to keep abreast of publications from the Regulatory Authority/Authorities who will be auditing your organisation, products, procedures and controls for GMP compliance.
Review the list of Regulatory Authorities for pharmaceutical manufacturing and medical device production.
Step 2: Evaluate your organisational charts and role descriptions
- What is it your employees, contractors and suppliers need to understand?
- Which GMP courses and PIC/S GMP Annexes will your trainees need to complete to be compliant with cGMP training requirements?
- What documented/signed role-relevant/product-relevant training have they already received?
- What training was completed:
- During their orientation period?
- In a previous job role or previous organisation?
- Since they were hired, even if that was 15 or 20 years ago?
- In the past 3 months?
- In the past 12 months?
- When regulations were updated? (Such as Annex 2A and 2B in PIC/S GMP Guide PE009-15 (PIC/s GMP Version 15)?
- When an SOP or Work Instruction changed or other modifications were made to manufacturing processes or products (e.g. a continuous improvement change/CAPA)?
A note for GMP Training Managers
A consultative approach is best when completing a Gap Analysis to determine your current GMP training program priorities and training schedules.
Current employees can provide valuable feedback on knowledge gaps, GMP compliance barriers, and confusion about Work Instructions and SOPs. Learn more about QMS/PQS document templates.
Contractors and qualified suppliers also generally lack adequate training as indicated by recent FDA warning letters and citations for cGMP compliance training gaps.
Reminder: Compliance with PIC/S GMP regulatory guidelines (with the FDA and TGA amongst 54 participating authorities ) requires ongoing GMP training such as refresher courses, as well as initial and ongoing training in:
- product-specific requirements
- PIC/S Annexes (e.g. ATMPs, biologicals, herbal medicines, medical gasses, etc.)
- your organisation’s current SOPs/Work Instructions
- contamination prevention/quality controls such as PPE/hygiene and cleanroom protocols
GMP training program management and recordkeeping requirements
Too often, training schedules fall behind due to production demands or personnel shortages.
- Late or missing cGMP training sessions are becoming more frequent because of increased demands for pharmaceuticals and medical devices during the pandemic, along with personnel absences and new hires.
- Onsite training may also not be properly documented or fail to be included in personnel employment files – a major oversight when it comes to GMP audits, remote inspections and self-inspections.
The risks of falling behind in GMP training sessions
This is another reminder of why data integrity/data governance measures are increasingly important.
This is also why self-paced, 24/7 online GMP training courses – which you can monitor completion of (as a Training Manager or Supervisor, when you purchase bulk courses for your team) makes a lot of sense for a variety of GMP education topics.
Step 3: Perform a gap analysis of GMP training gaps including competency assessments
This step involves getting a better grasp of the required skills and knowledge for each role type (and each person) in the organisation.
This step is likely going to require quite a bit of your time, depending on the organisation’s size, current production schedules (resource demands), and thoroughness of prior training records. But it’s a crucial step for training success.
- What initial training did each employee have in GMP compliance?
- Who provided it?
- Were all personnel provided with the same types and levels of training — or was there too much variance in how these employees were trained?
- What was the training documentation like?
- How thorough are their training records? (Do they meet GMP/data integrity requirements?)
- Are Department Managers and Quality Associates kept up-to-date with the GMP training status of production line personnel and/or contractors (and suppliers, where appropriate)?
- Does the current Competency Assessment indicate proficiency in the employee’s required knowledge and/or skillsets (for practical assessments) or is there a compliance gap in terms of education/training or qualifications?
Compliance with GMP regulations requires initial training and ongoing training that is adequate and product-specific, in relation to role responsibilities and product risks.
You must also regularly perform and fully document your employee Competency Assessments, training courses, and training needs.
Communication between the Quality Department, Human Resources/Training Departments, and Department Managers is crucial for ensuring your personnel receive required GMP training courses at an appropriate frequency.
Step 4: Create a plan that includes self-paced training as well as face-to-face training & live-streamed training sessions
Rest assured your GMP training records will be scrutinised during an audit. Training gaps are cited in numerous FDA warning letters, TGA audit findings, and other regulatory reports. A blended-training program, with ongoing sessions for each and all employees and contractors as required, is something many regulators will appreciate. Ensure they have product-specific training (e.g. the appropriate GMP Annexes and any relevant API containment/biosecurity laws if relevant to your products).
If an audit is looming, consider the fastest method for getting your teams up-to-date with GMP compliance training requirements. To save time as well as offer training flexibility to encourage completion (a must in today’s climate), best practice GMP education programs offer a variety of choices for training completion.
GMP training planning should include:
- Small group training sessions via on-site settings (when safe and appropriate to do so, during the pandemic, taking precautions where required)
- Video cGMP courses/digital classroom settings (webinars or live-streamed courses offered remotely, such as via ZOOM technologies) – an excellent choice when employees are working in different locations and have good internet access/bandwidth
- Online GMP courses such as product-relevant Annexes and Good Recordkeeping Practice training (online)
- One-one training with an expert (or mentor) in the fields/areas of work where personnel will be employed/deployed
cGMP best practice training tip:
Induction training and GMP refresher courses can readily be provided online for GMP regulations training, along with the FDA’s CFRs 210-211 (Finished Pharmaceuticals) and CFRs 800 & 820 (Medical Devices) and Good Record-keeping Practice (GRK). These provide you with an efficient, cost-saving way for learners to gain knowledge of regulations or to refresh their understanding of cGMP. Visit the GMP education topics pages.
Step 5: Seek direct feedback on the draft training plan
Feedback and written approvals for cGMP compliance training plans should be sought from the Department Managers as well as from involved personnel where appropriate.
- As you perform your gap analysis and/or circulate your initial training program plans, this is another good time to ask your Employees and their Managers/Department leaders — directly — what other training they may have completed in the last 12 to 18 months (that they have records for) and which areas of GMP they are unfamiliar with, or would like to learn more about
- But keep it confidential!
- While seeking feedback, keep one key requirement in mind: the training plan should be confidential in terms of keeping all competency assessments and individual training gaps (analysis reporting) secure and private/confidential, per your organisational policies and privacy laws.
- Typically only authorised manager(s) should be able to see these records and/or the employee being trained.
- Remember, Regulatory Authority representatives are going to be reviewing these documents –keep them professional!
- You’ll benefit from technical writing courses and should also take the deviations management course (yourself) for compliance writing tips. Find other facilitator-led compliance courses.
Step 6: Incorporate the feedback and create a timeline (pivot table)
Once you’ve incorporated the feedback from Managers and personnel:
- Create a pivot table of personnel, training courses, and timeframes for completion
- Note urgent training needs (colour code the sheet or names as appropriate)
- Include delivery methods or options (e.g. some courses may be available via a 1-day facilitated workshop as well as via an online training version)
- Check with the Department Manager (first) and the employee (second) before confirming the training schedule (to accommodate production line scheduling staffing needs and/or planned leave times)
Step 7: Fill in the details
What should GMP training records/training plans include?
- Required GMP education topics
- Full names and role positions of personnel and contractors who need to complete each GMP compliance courses
- Include the date of their last training completion and how it was delivered
- Recommended courses as well as optional training courses as appropriate (e.g. extra training may be required for certain roles and/or personnel who are new to GMP environments; e.g. Supplier Qualification, Release for Supply, Data Integrity)
- Suggested schedules for in-person/onsite or digitally-delivered courses
- Target dates for course completions (include a range if you believe staying on a precise schedule is difficult due to product demand fluctuations/production schedules)
- Allotted time (paid time) off from normal duties to complete assigned GMP training courses and which Project Numbers/Time Sheet Codes each employee should use (refer to your Accounting Department or the Department Manager)
It is important for Managers to plan which personnel or contractors will fulfil the duties of the trainee during scheduled training sessions in order to fill any potential production-line/packaging or distribution staffing gaps).
Step 8: Circulate for final reviews and management approvals
- Develop good working relationships with other Managers and while recognising they are busy, the more clarity in your documents (and the better prepared you are), the less work it is for them to provide quality insights and to give their approval(s).
- If at all possible, collaborate with the individuals themselves — the individuals who will be attending the training — when setting target completion dates or enrolling them in a set-date live-streamed GMP workshop or onsite session (when feasible).
- Remember to honour confidentiality and privacy rules – circulate only ‘department specific’ information to each Department Manager and ensure they keep this confidential from other employees
Step 9: Create clear documents, schedules, and summaries and circulate them
- Learn how to write with clarity and keep things simple
- Using graphs and charts can help but only if they’re easy to understand without having to read much
- Offer alternatives (such as eLearning or time off of normal duties) to keep the training completion progressing, especially in instances when employees are working remotely or have children-at-home they are needing to educate during normal working hours (as became increasingly common during the pandemic)
Step 10: Monitor progress and follow-up
The most important part of the program is checking that it is being delivered as planned, and is actually effective.
- Keep a close eye on progress (with bulk-purchased eLearning courses, you can actually track the progress and course completion dates of multiple employees at any time)
- If the schedule falls behind (and you know it will!), don’t pester individuals or Managers about their training completion date lapses as it could build resentment and take away from the satisfaction of doing the training
- Instead, get them involved directly in setting new course dates and completion targets (while keeping a pending audit date in mind), especially if they weren’t able to be involved in setting the original course dates
- Keep an Excel spreadsheet and circulate it to the designated parties as appropriate (remember confidentiality requirements for typical GMP knowledge/skills gap summaries)
- Ensure the training records are documented and legally signed
- Ensure originals and/or GMP-compliant copies are included in personnel records as well as your training program records (backups are a must!)
- Remember all of your records in a GMP environment are subjected to scrutiny and auditing – carefully what you put in writing, and be clear and concise yet also thorough!
Ready to purchase our online cGMP courses?
- Check out our customised bundles (select several courses in a bundle pack and save on your training budget!).
- Or contact us for training large groups of employees with either online courses and/or zoom-delivered workshops (onsite training is also available in Australia, New Zealand, and several other countries (depending on current travel restrictions).