Device specifications including; appropriate drawings, composition, formulation, component specifications and software specifications. Production process specifications including; appropriate equipment specifications, production methods, production procedures and production environment specifications. Quality assurance procedures and specifications including; acceptance criteria and the quality assurance equipment to be used. Packaging and labeling specifications. Installation, maintenance and servicing procedures and methods.

.What should go into the DHF and what should? Well not every change is worthy of documenting in your DHF, however if the following question are applied then you will capture the required records:
1) Did the design plan change?
2) Did a design input change?
3) Did a design output change?
4) Was the risk analysis affected?
You cannot have a change that affects verification or validation activities that doesn’t meet at least one of these four criteria. If any of these criteria are met, the change is significant enough that it requires documenting it in the DHF.

The manufacturer shall maintain device history records. The DHR shall include, or refer to the location of, the following information:
(a) The dates of manufacture;
(b) The quantity manufactured;
(c) The quantity released for distribution;
(d) The acceptance records which demonstrate the device is manufactured IAW the DMR;
(e) The primary identification label and labeling used for each production unit; and
(f) Any unique device identifier (UDI) or universal product code (UPC), and any other device identification(s) and control number(s) used.

This Matrix must sit along side your VMP or VP and together with these documents give a very concise overall picture of your validation program. This four part matrix allows you to list all the equipment and systems that must be qualified. Each entry is allocated a row in the matrix. The row consists of eleven headings, these may be edited as required (but come with all the standard documentation titles inserted). In this matrix there is room to enter the document number, prefixed by, A to D. The document number gives you the instant cross reference to the current document, the A to D prefix shows the progress stage.


Quantity

Typical of all our validation packages this validation package takes the strain out of validation. Just follow the guiding SOP's; that are integral to each protocol, through to completion, then sign off the protocols and start the protocol execution stage. Using the package guarantees that you will not run into discrepancies late in your execution program (this is the cause of the majority of validation delays).

The VMP must present an overall picture of the company facility. It must give a clear and concise overview, to a reviewer, of how the company has integrated all applicable cGMP requirements into its operations. It must define validation activities and allot responsibilities for authoring, reviewing, approving, and executing validation documentation and tasks. The execution of the VMP protocol must verify that there is an abundance of documented evidence to verify that these activities are continuous and on going.

The VP must specify methodologies, assign staff, designate responsibilities and give specific guidance on any contentious or ambiguous aspects of the VP validation task. Where it makes commercial sense and is compliant with cGMP rules and regulations; each VP can be written to cover multiple items.

The URS is produced once the product is established. With the product concept documented – then the design / recipe can be further analysed. From these investigations the requirements for facilities, utilities, maintenance, calibration, operator skills, software, documented specifications and engineering drawings can all be extracted and provisioned for.

Risk Based Validation was introduced to apply a level of validation that was adequate to maintain confidence in the qualification process; but would reduce unnecessary repetitive testing. The Validation Risk Assessment (VRA) was therefore designed to ensure that this level of validation is consistently used.

With a company approved VP and URS produced; vendors can be invited to submit submissions. These submissions will be challenged by the execution of a DQ; which will or will not certify that the vendor’s submission; if proceeded with, will fully satisfy all the requirements listed in the URS. Likewise when an Off-The-Shelf (OTS) purchase is proposed, then a DQ must be used to verify that this prospective purchase will satisfy all the relevant requirements, as listed in the URS.

A much used sequence of interrelated, cross referenced and sequential FDA mandated documents. The ideal package for the busy laboratory technician to follow. Simplicity personified; Finally the redoubtable fully detailed and interactive Operational Qualification (OQ) Protocol.

Simplicity personified; a Validation Performance Qualification (PQ) to set out scopes, responsibilities, time lines and methodologies, in a clear simple way that will not only please your regulators but will ensure compliance. THe fully detailed and interactive Operational Qualification (OQ) Protocols.

The SOP used to generate this IQ, takes you through the process line by line, chapter by chapter. It really is unique to find a SOP document so easy to use, all the work is done for you. All the documents are detailed, all the drawings listed and all the checks and tests detailed. The final product is a professional and comprehensive Installation Qualification Protocol. One that you can produce in less than 60 minutes. Yes, think about it, we all know how long producing IQ documents has taken in the past. There is now no reason for not being able to produce 4 to 8, IQ protocols per 8 hour day.

Document Statistics

Protocols = 1

Pages = 51

Paragraphs = 1030

Lines = 3240

Words =  6006

Characters = 38541

Graphics = 39

Size = 581KB