FDA and Personal Accountability.
have encountered many companies that claimed that they operated a ‘no blame
culture’, where employee regulatory compliance is questioned. They in their infinite wisdom seemed to
think this was perfectly acceptable.
The harsh facts are that the regulators expect everyone to be accountable
for their respective actions and are quite prepared (after due legal process) to
demand custodial sentences for serious infringements. We have on several occasions had to edit
client policy documents (in the light of regulatory comments) to reflect that
certain regulatory infringements by staff, would no longer be considered as
minor mistakes and would carry more severe penalties; such as employment
termination and accountability assessment.
Below is an extract from an FDA document regarding CAPA compliance; it is
informative to note how often they refer to the individual’s responsibility and
of the Corrective Action Operating Plan (CAPA) - The corrective action operating
plan should include:
analysis of the audit findings, including an analysis of-all identified
instances of wrongful acts associated with applications submitted to FDA,
identification all individuals who were or may have been associated with or
involved in the wrongful acts, and identification of defective practices,
procedures, products, and applications;
disposition of any recommendations made by the consultant;
description of the actions taken and to be taken to achieve correction of fraud
and other wrongful acts or deficiencies identified by FDA and discovered by the
timetable for implementation of the corrective actions;
of the persons responsible for taking and assuring the satisfactory completion
of each of the corrective actions according to timeframes;
comprehensive ethics program that describes standards for employees and
procedures for educating employees about the program and for enforcing the
procedures for monitoring the effectiveness of the operating plan and to assure
that the applicant can be expected to manufacture products in compliance with
current good manufacturing practices and application requirements.
addition, the corrective action operating plan should establish a mechanism for
assuring that supervisory, technical, and scientific employees are made aware of
the requirements of the Federal Food, Drug, and Cosmetic Act in their area of
responsibility, as well as the requirements under 18 USC 1001.
The Importance of Correct Procurement.
analysis of the end user's priorities, in procurement priorities, is made the
importance of the equipment / programs being validateable ranks at number two
out of ten. Second only to
delivery; with cost ranking around sixth. This has been true in over 80% of all
cases we have been involved with.
the-would-be purchaser, it gives enormous reassurance to know that regulatory
compliant validation protocols and plans are supplied. They are often willing to pay a 15 to 30
percent surcharge for these documents.
If a consultant is hired to produce the full suite of validation
documents (8/9 documents) considerable costs are involved. However it is the question; is the
system / program actually capable of being validated? That makes people hesitate. I doubt (after over twenty years as an
auditor) if there is any pharmaceutical company that has not at some time had to
abandon new programs or equipment for these reasons.
The FDA have
actually stated that 70% of validation problems are directly related to none
compliant procurement methods.
comments about you having to validate the equipment or program are completely
erroneous. The end user has that
task; your task is to ensure that your product is validatable. That means in all ways it must be
compliant with the applicable directives in cGMP. On our site we carry further details of
all these requirements.
Some of Our Current Fast Moving Documents.
Software Validation SOP (Issue-2) -- $22.00
Software Validation Master Plan (issue-2) -- $115.00
Software Validation Risk Assessment (Issue 2) -- $125.00
Software User Requirements Specification. (Issue 2) -- $115.00
Software Validation Plan (Issue 2) -- $89.00
Software Design Qualification. (Issue 2) -- $89.00
Software Installation Qualification. (Issue 2) -- $89.00
Software Operational Qualification. (Issue 2) -- $89.00
Software Performance Qualification. (Issue 2) -- $89.00
Software Validation Package (Issue 1) -- $699.00
A recent warning letter demonstrates just how few companies use a Gap Analysis to validate that they are compliant. CAPA discrepancies continue to be the biggest single source of problems. However the daddy of them all recently has been a well known company that had carefully documented the levels of experience and educational standards required for various GMP sensitive roles (In accordance with GMP), only for the FDA to find the persons in these jobs were not qualified properly. (click here to read)
Do use a Gap Analysis and avoid these embarrassing events.
Gap Analysis Tool (Issue 2.) -- $115.00
Validation Risk Assessment (Issue10.) -- $125.00
This popular Validation Risk Assessment (VRA) has now been edited and enlarged to include Part 11 assessment tables for you to use in classifying which of your predicate records require to be stored in compliance with 21 Part 11, and which do not. It also includes an Excel spreadsheet to allow you to establish a permanent record of all such judgements, as is now mandated by the regulatory authorities.