Once again, I am onsite and attending weekly validation progress meetings, along with the usual collection of project meetings. Once again, I am surprised and shocked by the utter lack of comprehension and ignorance of so many contractors, clients and equipment suppliers, regarding the basic requirements of a successful validation project.

To sit in at meetings, and listen to protocol authors stating what they want to see in facility validation protocols, is nauseating. I just could not listen any longer to technicians beefing on about light fittings, surface finishes, door steps, so, I had to interject, and point out some basic home truths to them. Such as, this building along with all the installed plant, was designed to conform to the regulatory requirements for such a facility and the clients requirements, and further the design was completed, reviewed, approved and frozen, with the execution of a Design Qualification. therefore their protocol must only verify that the building was built in accordance with the drawings, not their own opinions, thoughts or wishes. The client had accepted the approved design, and went to quotation for construction.

They also needed to be directed that their equipment descriptions in both the IQ and OQ, and indeed any other validation protocols, are only there to inform any authorised person who reads or reviews the protocol, what the basic functionality of the system / equipment is, and what part it plays in the production cycle of the regulated product. You are not validating their write up. Sometimes this attitude even permeates from the client. Recently I had a case, where the validation manager had approved protocols calling for room laminar flows to be verified using smoke and photography. The only problem was that laminar flows were never specified and the HVAC inlet and outlet filters were all in the ceiling, precluding any possibility of attaining laminar flow. He was quietly euthanized.

DO YOUR URS, THEN YOUR DQ, THEN PUT THE WHO, WHY, AND WHAT, OF ALL YOUR PROPOSED VALIDATION ACTIVITIES INTO YOUR VP / VMP.

Then guess what, the IQ’s, OQ’s and PQ’s, will just flow, since every one will have exact terms of reference to work to.

Wyeth gets it right, At Last

"We are pleased that FDA has re-classified the Guayama facility and we were able to resolve its concerns in a satisfactory manner. The change in status allows for the timely approval of new products manufactured at the site," says Bernard Poussot, President, Chief Operating Officer and Vice Chairman, Wyeth.

From FDA Warning Letters:-

These are all current (2007); Really it is no wonder that the regulators get angry and frustrated. One installation they were at, the equipment was covered in cobwebs, another one you could not read the machine ID plates because of encrusted power dust. There is no excuse for this; First impressions count and last.

The comments listed below are repeated time and time again, in warning letters issued this year.

Failure to adequately validate and approve according to established procedures a process whose results cannot be fully verified by subsequent inspection and test as required by 21 CFR § 820.75.

Failure to establish adequate procedures for identifying training needs and to ensure that all personnel are trained to adequately perform their assigned responsibilities; and to document training, as required by 21 CFR 820.25(b). For example:

The Production Manager at XXXX Plastics stated that all employees are given training on good documentation practices. However, this training is not documented. During device history record (DHR) review, write overs, erasures, and correction tape were observed in all eleven (11) DHRs.

Failure to establish and maintain procedures to ensure that equipment identification, calibration dates, the individual performing each calibration, and the next calibration dates are documented and this documentation is displayed on or near each piece of equipment or readily available to the personnel using such equipment and to the individuals responsible for calibrating the equipment, as required by 21 C.F.R. § 820.72(a) & (b)(2). For example:

Failure to assure that when computers or automated data processing systems are used as part of the production or quality system the manufacturer shall validate computer software for its intended use according to an established protocol, as required by 21 CFR 820.70(i). No procedures are established to validate for its intended purpose the Microsoft Word or Microsoft Excel software used in creating and maintaining nonconformance records, product return records, internal audit corrective action records, or preventive action records.

Off-the-shelf software must be validated for its intended purpose. You have stated that a review will be conducted of the existing forms and an implementation of a new record control system to meet FDA requirements will be pursued. No procedures have been submitted for review and no timetable for corrective action and response was indicated.

A. SOP P11.01 Calibration, effective November 10, 2000, states that your firm will maintain an Equipment List and include calibration and maintenance requirements for each piece of equipment on this list. However, your firm does not have an Equipment List, has not identified the equipment requiring calibration, and has not documented any justification as to why the equipment requires no calibration. Additionally, your firm does not include the specifications for the equipment requiring calibration or have a written calibration schedule identifying the frequency of calibration for the equipment.