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Compliant Documentation.

In the qualification of equipment and processes, precise and properly scoped documentation is mandatory.
Validation Documentation, such as, (URS, DQIO, OQ, P1Q, P2Q
However, there are many manufacturing processes that produce a product or part of a product that cannot be tested (Compliant Documentation.) without damaging it, or indeed destroying it.  The introduction of QA allowed manufacturers to build and destructively test, then using rigorously enforced quality controls replicate the tested product exactly, now knowing its performance and limitations.  Pharmaceutical, bio-pharm and medical device companies must demonstrate to the regulators that their whole operation is under similar control.  Quality Control that will ensure all operations are documented, all materials are verified as correct and all equipment is qualified as fit for purpose.  
All this Compliant Documentation must be in place and in operational use, prior to receiving regulatory approval to manufacture.  This status must be maintained to a standard that ensures consistent replication of all the production processes and without ever compromising the quality of that product.  The maintenance of these standards is called continued Good Manufacturing Practice (cGMP).  This qualified or approved state is subject to continuous ministering and inspection by the regulatory authorities involved, as long as the product is in production.



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No. 112, Comments, cGMP FDA 483 inspection.

Cold Chain Insurance.

Three words that are beginning to generate concern, as clinics around the world read about vaccines that were found to have been damaged during transit and or stowage, by being stored in faulty refrigerators. The regulators are mandating that documented history of the stowage temperature of these drugs be available for review and that this history must be continuous from manufacture to actual use by the end user.

The regulatory requirements are there for all to review, so do not be surprised when you are asked to produce them. In the UK thousands of people are being re-injected to try and ensure protection. What will happen when a protected person becomes infected by the very infection they are supposed to be protected from?

No. 111, Comments, cGMP FDA 483 inspection.

US 500 million in Fines.

Just when people are relaxing, thinking regulatory pressures are easing, old sores are highlighted again. Question are being ask about improvements since the acticle below was published, and no improvements can be found. Expect new pressures from the legislators to the regulators.

The Wall Street Journal recently published an article informing all that pharmaceutical “manufacturing techniques lag behind those of potato-chip and laundry-soap makers.” The same article correlated the rise in recalls with quality problems and noted that despite fines in excess of US$500 million for manufacturing failures, acceptable levels of quality were not being achieved.

No. 110, Comments, cGMP FDA 483 inspection.

Serious Product Contamination.

The normal requirement in designing equipment installation is that all powered valves must fail into a safe condition.

So with a loss of power (pneumatic or electric) a : -

A steam supply valve will fail shut.

A supply valve to a vessel (water – product – whatever) will fail shut.

A steam exhaust valve will fail open.

A drain valve will fail open.

Now take out your P & ID for your mixer / homogenizer / blender process stage and follow through from the main vessel body.  You have a route from the vessel to a destination for your product, there will also be a route to drain, used during vessel cleaning.

When the equipment is installed in a clean room environment the waste must be plumbed all the way (no air breaks allowed in clean areas) to a waste drain, in most cases all the way into the waste drain.  Air breaks are allowed, but not within the atmospherically controlled area.

Now consider the powered down condition, the week end, the HVAC is running maintaining room condition, but all equipment is powered off.

You have a route from your mixer vessel interior, all the way into the plant waste system.  If your room is being held at a negative pressure , then your HVAC is drawing foul air from your waste system through the mixer and into the room.  Even if this is not the case, biofilms will slowly grow all the way along this route.

On a recent green field site 14 mixers were found to be connected up this way.  In a plant that had four mixers in use for six years, all were connected this way.  In this case they had been blaming product contamination, on their quality water system, and had spent a great amount of time and money furiously chasing it around their plant room.

No. 109, Comments, cGMP FDA 483 inspection.

Application of 21 CFR Part 11.

21 CFR Part 11, applies to electronic records and signatures. If we consider the records aspect, then 21 CFR Part 11 does not apply to electronic raw data, this is not considered to be a record. If data is held in a none editable format, Part 11 does not apply. Once the data is stored in any format that can be accessed, it must be protected against illegal access and must be compliant with Part 11, to prevent adulteration.

A Validation Risk Assesssment (VRA) must be carried out to ascertain the regulatory requirements of the data. The VRA outcome must determine the level and scope of validation required, for the raw data generation and handling equipment, and the data record keeping equipment.

No. 108, Comments, cGMP FDA 483 inspection.

Ensure you have a plant maintenance schedule and all critical plant equipment is listed and that current (validated) installation drawings are avaiable. Also verify that their maintenance frequency is documented and justified.