VALIDATION ONLINE DOCUMENTATION CENTRE. Introduction to Validation Online Services.
Validation Online offers you professional assistance and advice to assist your endeavours in finding the most cost effective solution for your validation requirements. Over the past decade our team of highly experienced consultants have worked with most of the major Bio-technical, medical and pharmaceutical companies in the world. Their time has been spent not only in satisfying the necessary regulatory requirements, but in also ensuring that the most cost effective methods of doing so were and are used. To ensure the concept of cost effective regulatory compliance was and is maintained, Validation Online used the vast field experience of its multi-disciplined team of consultants, to design and perfect a completely new suite of interactive and fully detailed validation online documents. Documentation that is written, in an easy to edit, word format, that is interactive, fully referenced and fully detailed. Documentation that was authored and targeted for the specific worldwide use of the busy technologist or manager. To enable such people to quickly raise and issue fully detailed, complaint and professional documents.
Need equipment validated in a hurry and in
the most cost effective manner possible?
Well, that is no longer a problem. Simply select the protocols you require and an electronic interactive questionnaire will be instantly emailed to you. Complete the questionnaire and then click on the 'Submit Button'. One of our validation online specialists will then, use the information on the completed questionnaire and an appropriate in-house template to produce a fully detailed, bespoke, ready to use, validation protocol for your use.
The Importance of Humidity Sensor or Hygrometer Calibration
Humidity sensors require frequent calibration and continual monitoring, they are, the most prone to error sensors in general facility use. Where as most sensors measure to within (plus or minus) 1% and have have extremely low drift rates. Most humidity sensors measure to within (plus or minus) 3% at mid range and 5-7% at the top and bottom of their ranges, and have a significant drift rate. In a standard HVAC system, a humidity sensor that over reads the incoming air humidity will drive the cooling coils to maximum chill, as it tries to remove the moisture it is erroneously sensing. This severely chilled air then requires maximum heating from the heat coils to attain and maintain room temperatures. This vicious energy burning situation often goes completely unnoticed and can increase energy consumption by as much as 600% per AHU. This is the very reason that humidity sensor accuracy is one of the most important energy conservation concerns. Read further .. Humidity Calibration Kit descriptions. Humidity Calibration Kit Purchase . From: VAISALA
news No humidity instrument stays accurate on its own. From time to time, the performance of these instruments must be checked against a reference.
When calibration is done in-house, the use of saturated salt solutions as a reference is a proven and affordable method. Validation project or equipment to execute? Then use our most popular document suite. When you use our suite of inter-related and interactive documents the qualification task is properly scoped referenced and detailed. No loose ends. It becomes a smooth flowing efficient task, with progress and completion times being accurately predicted and achieved. Traceability of testing is maintained from the URS, to the PQ, a cGMP requirement. Validation Online Packages are available for most tasks. Click below, then select the section applicable to your requirement and view the packages available.  New to validation Online or looking for company SOP?
Validation Online have just released our Standard Operating Procedure for Equipment Validation - This SOP takes you through the validation process for equipment, from the very early first stages, to the final closing stage. It will ensure that your validation is seamless, and that the correct documents are raised, approved, executed, reviewed and accepted correctly. It shows how to use validation tools such as the very important matrix control document and equally important risk assessments, along with the integration of the three level URS. Protocols, such as the IQ, OQ, DQ and the PQ , along with the essential VMP, VP, URS, VRA and often an FMEA, make up a range of regulatory required documentation that has been used on behalf of many clients and has been repeatedly subjected to Regulatory Authority scrutiny. These, Part 11 compliant documents are continually under GMP review by Validation-Online to ensure that they conform to the regulators current requirements and expectations. These standard format validation protocols are complemented with the addition of detailed specific protocols such as Computer System Validation (CSV)- VMP - IQ - OQ -IQ/OQ, HVAC IQ - OQ - PQ, and Facilities IQ - QO - PQ. - REDUCE YOUR VALIDATION COSTS - Why use up your budget authoring new
VMP’s, URS,
VP
,
and GxP documentation for each and every validation project you are
involved in, when there is quality documentation, at budget prices,
available in minutes from Validation Online. Documentation that you can instantly down-load, and convert in minutes, from a generic, to a company bespoke document, using the attached detailed SOP. The SOP is an impressive tool to use, taking you quickly (section by section)through the document completion process. You can show a massive saving in the normal project validation budget, by using these documents. Result is, you look good and so does the project time line. - USE PROVEN QUALITY DOCUMENTS - Download, the Validation Online, generic
Installation Qualification Protocol (IQ) or Operational Qualification
Protocol (OQ) directly from Validation Online, auto populate it in
minutes, run through the attached SOP and transform the document into
your own bespoke company document in 20 minutes, complete remaining
requirements in 30 minutes, and issue for approval signatures, all in
less than 60 minutes. Repeat this process for many other regulatory
required documents and protocols.
- FAST PRO-ACTIVE PROTOCOLS FOR YOU - A recent survey highlighted that 32% of all equipment procurement is unsatisfactory simply because the companies concerned did not accurately request what they actually needed. This is why the User Requirements Specification is such an important document. Use the right up to date URS from Validation Online (User Requirements Specification), the only URS available that uses a three level approach to ensure that
the traceability demanded for life-cycle validation, is maintained.
Auto populate it, and follow the SOP to complete it, then you have the required regulatory traceability from your User Requirements Specification (URS) to the
Design Specification (DS) that the regulators now demand. This document ensures that a fully referenced and traceable DQ can be developed and executed, it also simplifies validation, especially software validation.
- DOCUMENTATION JUST RELEASED. - As a consultant, the most often asked for service as soon as you arrived in a clients office is, a GAP ANALYSIS. It is what everyone wants, a detailed review of all aspects of your current systems to determine compliance and adequacy of current procedures. A gap analysis involves comparing regulatory requirements against current procedures and facilities in your facility. Every One Talks It – Very Few Have It – Get Yours Now. – Click Here.
The
Compendium of Predicate Rules (CPR) has been published to satisfy a requirement that has existed for some time now. It enables you to reference the correct cGMP identity for your requirement, when working with compliance documents. It acts as an aide-mémoire and allows you to be correct and accurate every time. No more boxing around with requirement descriptions - reference your requirements exactly. A really essential tool for all compliance professionals. The Computer Master Validation Plan (CVMP) along with the Computer System IQ, and the Computer System OQ, and the totally new combined
IQ & OQ, for the smaller or simple piece of equipment (perfect for laboratory equipment). Three very sought after documents, in the same interactive style, complete with detailed SOP’s to lead you painlessly through the validation of computers, computer systems and or computers integral to equipment.
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No. 112, Comments, cGMP FDA 483 inspection.
Cold Chain Insurance.
Two words that are beginning to have a lot of significance. Clinics around the world are now reading about vaccines that were damaged during storage by being stored in faulty refrigerators. Now the regulators are demanding temperature history documentation for vaccines and other temperature sensitive drugs, from manufacture to use.
The regulations 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.