FDA and Personal Accountability.
We 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 accountability.
Content of the Corrective Action Operating Plan (CAPA) - The corrective action operating plan should include:
v An 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;
v The disposition of any recommendations made by the consultant;
v A 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 internal review;
v A timetable for implementation of the corrective actions;
v Identification of the persons responsible for taking and assuring the satisfactory completion of each of the corrective actions according to timeframes;
v A comprehensive ethics program that describes standards for employees and procedures for educating employees about the program and for enforcing the program; and
v 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.
In 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.
When an 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.
For 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.
Your 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.