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Pre-Inspection Activities
Proper preparation work is vital for ensuring that your company successfully passes a PAI.
It is highly recommended that preparation work starts at least 12 months before the date when
you plan to contact the relevant authority.
An initial PAI meeting should be held to define the responsibilities of individual PAI team members
and milestones must be set in order to monitor the progress of preparation work. Our website offers
a range of tools and guides that help ensure your preparations for a PAI run smoothly. PAI protocols
for drug products and active pharmaceutical ingredients have been created to systematically identify
the strengths, opportunities, weaknesses and threats associated with organization, personnel, quality
systems, facilities, utilities, water systems, clean steam, HVAC, gases, equipment, key raw material
suppliers, manufacturing process synthesis, sieving, milling, micronisation, analytical testing, test
method validation, method transfer, stability, laboratory equipment, microbiological testing,
contractors/suppliers and inspection issues (» checklists).
These protocols enable you to identify any potential shortcomings during the early stages of preparation
work, usually 6-12 months before the submission of a new drug, and give you the opportunity to resolve
the issues or finalise pending work and reports in good time.
The FDA is also increasingly focusing on the validation of computer and/or computerised systems and
compliance with 21 CFR Part 11 on a risk-based evaluation. It is vital that you are well prepared in
these areas (» checklists)!
Companies should be aware that preparing for a PAI is not a last-minute activity. It is clear from
current warning letters that SOPs are still extremely important. One of the most likely reasons for
this is the FDA’s new systematic approach. Common observations for SOPs relating to key issues such as
deviation, OOS, change control and training are that they are often too convoluted or general and
sometimes workers are not given sufficient training in how to implement them. Many warning letters
also cite incomplete document history files or outdated SOPs. Generic SOPs are available on our website
to help you avoid such pitfalls and only need to be adapted slightly to suit your company
(» SOP's).
It is also advisable to organize comprehensive training for the personnel who are to participate in a
regulatory authority inspection. Indeed, it is widely recognised that personnel who behave in an inappropriate
manner or provide misleading information can cause inspectors to look into areas where they previously had
no concerns. The same applies to the misinterpretation of questions and the use of phrases that should be
avoided such as “I think”, “I suppose”, “I guess”, “normally”, “usually”, “occasionally”, or “mostly”.
It is vital that all personnel who could potentially come into contact with an FDA investigator undergo proper
training on how they should conduct themselves during an inspection. It is important to remember that there is
a whole range of do’s and don’ts that must be followed in all circumstances.
Troubleshooting and Gap analysis conducted by the PAI team provides a further useful tool. This “organized brainstorming”
meeting is designed to list all potential strengths, opportunities, weaknesses and threats. Everyone taking part in the
meeting must be able to speak openly and honestly when discussing where they personally see potential risk areas or
weaknesses. Senior management are often surprised by how much is already known within an organisation, but is not
communicated to the people who are able to change and improve issues that may have caused problems in the past but were never resolved.
It is crucial that you closely examine the findings of any previous inspections and the commitments that were given
to the agency as inspectors often use these as a starting point for their work.
Shortly before the inspection, a key contacts list should be compiled detailing the names, positions,
phone numbers, mobile numbers and e-mail addresses of the most experienced personnel. This will ensure
that information flows rapidly and smoothly during the hectic inspection period.
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