WHO guideline: Pharmaceutical quality control labs should plan ahead for operational disruptions

Prompted by the global challenges brought on by the COVID-19 pandemic, the World Health Organization (WHO) is recommending that all pharmaceutical control labs – whether private or national – should maintain proven crisis management plans to keep them running as smoothly as possible when serious trouble strikes.

It’s the first update on guidance for national pharmaceutical control labs since 1999, the organization said.

The revision contains a brand-new section on strategic planning, which recommends that labs beef up their management tools to help ensure continued operations should another large-scale challenge threaten operations and productivity. It also contains revisions to sections on performance evaluation, risk management, crisis management, communication management and measurement uncertainty.

“[The] COVID-19 pandemic has made clear that risk management, crisis management and business continuity are subjects which should be addressed to ensure that laboratories are prepared to face similar situations,” the 83-page draft document notes. The guidance “provides advice on the quality management system within which the analysis of pharmaceutical products by quality control laboratories should be performed to ensure that accurate and reliable results are obtained. Compliance with the recommendations provided in these guidelines will help promote international harmonization of good laboratory practices for pharmaceutical quality control laboratories and facilitate mutual recognition of test results.”

The document also contains a special note soliciting specific comments on a subtle, but important, change in wording in one section from the 1999 guidance.

“In the previous version of the guideline, the requirement for having ‘a policy for participation in appropriate proficiency testing schemes and collaborative studies and the evaluation of the performance’ was ‘applicable to national pharmaceutical quality control laboratories but may be applied by other laboratories.’ With the revision of the guideline, this requirement shall become applicable to any pharmaceutical quality control laboratory, be it a quality control laboratory of a pharmaceutical manufacturer, a commercial laboratory, a third-party contract laboratory or a national quality control laboratory.”

It's critical to have a crisis management plan fully vetted and ready to implement, the guidance says.

“Business Continuity Planning allows the laboratory to take effective measures when issues or an incident arise, enabling management of those issues and providing continuity of business. Thus, key functions of the business, in particular key public health functions, can be fully recovered in the shortest possible time at acceptable costs.”

Such a plan should be constructed with input from lab personnel and key stakeholders and document actions that will protect both people and business assets in the face of a natural disaster, IT breakdown, cyber-attack or pandemic.

It should also include an analysis of potential risks to the facility and the impact they could have, as well as a plan to mitigate those risks and recover critical capabilities.

The plan should be tested and reviewed periodically. An adequately trained continuity team should oversee establishing, implementing, and – if necessary – adapting these recovery strategies.

It’s not enough to just write up a plan and get everyone to agree on it, the guidance stresses. It needs to be tested and disseminated among everyone involved.

“The laboratory should test the business continuity plan established, e.g., by simulation, to confirm its suitability for the intended purpose. Other departments within the organization [if applicable] and stakeholders should be informed whenever a situation capable of presenting a risk to public health occurs and the remedial actions taken.”

That means being on-point with intra- and inter-office communications.

“The laboratory should ensure that staff and stakeholders are informed and are aware of the results of performance monitoring, either from management review or from other monitoring tools. A laboratory that is part of an organization, such as a National Regulatory Authority or manufacturing company, should have communication channels with other parts of the organization that are defined and established to facilitate decision-making processes and other relevant processes.”

The draft document also contains guidance pertaining to:

Organization and systems management: records and data control, corrective and preventive actions, internal audits and complaints
Resources: personnel, premises, reagents and reference materials
Technical activities: Sampling and handling of samples, validation of procedures, testing and evaluating test results, out-of-specification results, non-conforming work and reporting
Safety

Once approved, the new guidance will apply to both private and national pharmaceutical quality control labs. Labs that test biologicals like vaccines and blood products, or microbiological labs, are covered in a separate guidance.

WHO is accepting comments on the draft guidance through Oct. 6. Comments may be submitted through the WHO input portal. Commentors will need log-in credentials, which can be obtained by submitting name, address, and organization to [email protected].

WHO guideline: Pharmaceutical quality control labs should plan ahead for operational disruptions

Related topics

Recommended content

Welcome to the new RAPS Digital Experience