FDA guidance on recall readiness
The FDA’s updated guidance on recall procedures seeks to ensure manufacturers and distributors of pharmaceutical products and medical devices remain ‘recall ready’ at all times.
Recalls of therapeutic goods are not uncommon. As part of implementing a ‘best practice’ Quality Management System (QMS), you need to ensure your company is well-prepared to implement a rapid, and thorough, product recall.
While avoiding a recall relies on the use of effective procedures for deviations and non-conformance management, implementing CAPAs, and other risk controls — if a recall does become necessary — how prepared is YOUR team?
- Recall delays, poor distribution recordkeeping, and procedural oversights can lead to harm — or even civil or criminal charges for negligence.
- So you need to ensure your team is ‘recall ready’.
- This includes ensuring your personnel are ready to manage an after-hours recall event.
Recall delays can be deadly
Recalls remain a concern for every company in the industry. As with all things in life, things can (and do) go wrong. Being well-prepared to implement a recall has the capacity to save lives, protect public health, and protect healthcare providers, your company and your employees.
Ensuring your employees and distributors are ‘recall ready’ — and that your recall procedures are effective — is an absolute necessity. This remains true even for companies who have assessed their product recall risks as being ‘relatively low’.
Need to update your team relating to the latest recall guidance from regulators such as the TGA, FDA, EMA, MHRA, and others? Start them off with the certificate GMP training course covering Therapeutic Goods Recalls – an online training course suitable for a worldwide audience (click here).
Regulatory expectations for ‘recall readiness’ – FDA & TGA examples
Companies are expected to be ‘recall ready’. Preparedness for recalls is one of the key compliance items evaluated during GMP compliance inspections (Regulatory Audits), by representatives from the FDA, TGA, and other Competent Authorities or Notified Bodies.
In fact, numerous regulators have released updated guidance for Recalls of Therapeutic Goods. Take, for example, the TGA’s updated guidance for their Uniform Recall Procedure of Therapeutic Goods (URPTG) updated to V2.3, effective 30 June 2022 and the FDA’s guidance on being “Recall Ready” (updated on 4 April 2022).
Training personnel: preparing for a recall
Recall procedure complexity can vary depending on the product type and product distribution channels.
- The challenges of preparing for a potential recall are complex.
- That’s primarily because recall readiness needs to be considered whenever designing or revising QMS policies and procedures or performing self-inspections/GMP compliance audits.
The difficulty in staying prepared for a product recall primarily relates to the fact that recalls are often rare occurrences for the majority of pharmaceutical and medical device companies.
Complex manufacturing processes and distribution channels, often spread over many geographical regions — as well as changes to logistics service providers, warehouse and distribution personnel — can challenge a company’s best efforts to ensure “recall readiness”.
In the eyes of a Regulatory Authority representative — is your team truly ‘ready for a recall’ — or would you struggle to put it into place in a timely manner, compliant with the latest FDA or TGA guidance for implementing recalls?
Impact of the pandemic on medical product recalls and GMP compliance
- In times of personnel shortages (due to the pandemic), companies may also face challenges in sustaining adequate GMP compliance training by high employee turnover rates in the pharmaceutical sector.
- High turnover places increased demands on the Quality Team, operations managers, and training programs.
- So, too, does the impact of changing raw material suppliers, packaging contractors, and/or warehouse storage, & distribution service providers in response to medicine supply chain interruptions.
The unpredictability of recalls
Staying prepared requires training and resources
- Recalls are generally unpredictable.
- However, the discovery of an SAE, regulatory inspection finding, non-conformance or OOS event (or complaint investigation finding) could lead to a recall becoming necessary.
How can you ensure your personnel will be skilled at implementing recall activities and recall communications in a timely, effective, and thorough manner?
- How can you ensure your recall procedures will be effective?
- What resources must you devote to recall preparation?
Being ‘recall ready’ – basic steps
Start with a review of your recall procedures and ensure your recall training is up to date
The FDA, for example, issued additional ‘recall ready’ guidance in recent years.
- To be ‘recall ready’, you must have appropriate procedures in place, and regularly review them to ensure effectiveness.
- You must also nominate & document who in your company will be responsible for which recall activities (as well as nominating backup personnel).
- Some regulators, but certainly not all, have started to expect mock recall exercises (recall drills) depending on the product type and product class (risk class).
- Read the article: ‘Are mock recalls expected?’
Organising a Product Recall Team
Employees tasked with recall activities must understand their recall responsibilities in your company’s jurisdictions of distribution.
- They must be appropriately trained and qualified to fulfil their recall responsibilities.
- After-hours recall communication strategies, internally and externally, must be kept up to date and regularly reviewed for effectiveness (e.g., during Management Review meetings).
- Even where a mock recall is not required, it makes good business sense to have practice sessions on an at-least yearly basis.
- If you are in Australia, for example, you need to understand the latest guidance in Version 2.3 of the TGA’s URPTG.
- If the distribution of your product is in the USA, you must understand the FDA’s updated recall guidance (March 2022), as discussed in their April 2022 podcast on Key Elements of recall procedures.
Data integrity: a crucial component of an effective recall plan
It’s no secret, either, that recall preparedness depends on ensuring good documentation practices (GDocP or GRK) and other measures to ensure data integrity compliance.
Good recordkeeping starts during the earliest product design stages and needs to continue throughout the product’s life cycle; from incoming material receipt through to manufacturing, distribution to patients, and beyond (post-marketing surveillance activities).
Click here for good recordkeeping and data integrity compliance training (online).
FDA recall guidance in 21 CFR
The FDA’s 21 CFR Subpart C (Initiation of Voluntary Recalls) final document for Recall readiness was released in March 2022. This FDA ‘recall readiness’ update was followed by a podcast (“Key Elements of recall readiness”) published in April 2022.
- The FDA’s 21 CFR Subpart C on product recalls applies to pharmaceutical manufacturers and medical device manufacturers as well as their distributors.
- Link to FDA 21 CFR Subpart C: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/initiation-voluntary-recalls-under-21-cfr-part-7-subpart-c
Medical device corrections and removals (21 CFR 806 – recalls)
Medical device manufacturers and distributors should also refer to The FDA’s 21 CFR 806, (Part 806 – Medical Device Correction and Removals).
What is meant by an ‘FDA Recall Order’?
An FDA recall order is essentially a mandate, compared to a recall implemented ‘voluntarily’ by a manufacturer in response to an identified hazard, an audit finding, patient complaints, SAE events, and/or other risk-related events.
In rare instances, if a company or distributor/importer fails to voluntarily recall a device that is considered a risk to public health/patient health, then the FDA may issue a recall order to the manufacturer under 21 CFR 810, Medical Device Recall Authority. “The 21 CFR 810 describes the procedures the FDA will follow in exercising its medical device recall authority under section 518(e) of the Federal Food, Drug, and Cosmetic Act (Act).” (Source: FDA)
Under 21 CFR 806, Medical Device Correction and Removals, manufacturers and importers are required
Brief summary: FDA recall preparedness requirements
In brief, how does a pharmaceutical or medical device company stay ‘recall ready’?
Sampler from the comprehensive Therapeutic Goods Recalls training module (overviewing guidance from the TGA, FDA and more).
Up-to-date Recall Procedures
- Ensure your procedures for recalls are kept up to date.
- Establish clear communication protocols.
- Ensure your procedures cover all distribution regions and out-of-hours communication protocols.
- Ensure recall procedures undergo review by Management (effectiveness checks).
Trained Personnel
- Identify which employees are going to be responsible for recall activities including communications.
- Clearly document and communicate personnel responsibilities and procedures in your organisational charts and QMS (Quality Management System).
Ongoing Recall Training
- Train your employees thoroughly and repeatedly – the Recalls of Therapeutic Goods online training course, covering recall guidelines and recall preparedness expectations, is an excellent primer and refresher course.
- It is suitable for a wide variety of employees.
Batch Recordkeeping/Traceability
- Good documentation practice/good recordkeeping practice must be company-wide and include suppliers and distribution companies.
- Ensure your Warehouse & Distribution (logistics and shipping personnel)
- Click here for Certificate Courses (online) in GMP, good recordkeeping, good warehouse practice and good distribution practice.
Internal audits
- Conduct self-inspections to ensure compliance with expectations.
- Implement prevention measures.
- Ensure your procedures for detecting deviations and non-conformances, and for implementing CAPAs, are effective.
Data Integrity Reminder for Recall Preparedness
While certain employees are tasked with recall implementation, you still need to ensure your entire team — from source material providers to warehouse and distribution personnel (including practitioners delivering medicines such as vaccines and ATMPs) — keep accurate records.
Additional Recall Resources and Articles
Deviations & quality defect investigations
When was the last time you trained your employees in your recall procedure? Are you sure your procedure is effective, and that your employees and distributors are ‘recall ready’? Could you effectively handle an out-of-hours recall event?
Train your GMP manufacturing and distribution personnel in Good Documentation Practice, Deviations and Non-Conformance Management, Good Warehouse Practice (GWP) & Good Distribution Practice (GDP).
Train your personnel with online GMP training courses: or with onsite or internet-delivered virtual training facilitated by GMP experts.
Browse our GMP Education courses (Certificate GMP Training Courses) with trackable completion rates for your training department records/PQS records for personnel and contractors.
For onsite training for groups of 10 or more employees or for online GMP course training bundles for over 50 employees, use the ‘contact us’ page for a quote.
Resources and Additional reading
BCC journal articles: Counterfeits during the pandemic
Designing a resilient supply chain: An approach to reduce drug shortages in epidemic outbreaks
Last updated on July 6th, 2023 at 12:23 pm
