Quality manual policy

Knowledge management is a systematic approach to acquiring, analysing, storing and disseminating information related to products, manufacturing processes and components. Sources of knowledge include, but are not limited to prior knowledge public domain or internally documented ; pharmaceutical development studies; technology transfer activities; process validation studies over the product lifecycle; manufacturing experience; innovation; continual improvement; and change management activities.

Quality risk management Quality risk management is integral to an effective pharmaceutical quality system. It can provide a proactive approach to identifying, scientifically evaluating and controlling potential risks to quality. It facilitates continual improvement of process performance and product quality throughout the product lifecycle. ICH Q9 provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality.

Design and content considerations a The design, organisation and documentation of the pharmaceutical quality system should be well structured and clear to facilitate common understanding and consistent application. The design of the pharmaceutical quality system should incorporate appropriate risk management principles.

While some aspects of the pharmaceutical quality system can be company-wide and others site-specific, the effectiveness of the pharmaceutical quality system is normally demonstrated at the site level. This can be the case for those that are not familiar with the standard, find themselves backed into a corner by a current customer or It also requires the careful and considerate oversight of your By Scott Dawson.

June 22, It is first important to understand exactly what a Quality Manual is. Uses of a Quality Manual In addition to a tool for managers, the manual can be used for several other important purposes. Content: What to Include For users of ISO , the contents of your quality manual are completely up to you, and are largely dependent on your processes.

Here are some common topics included in quality manuals. Development: Quality Manual Creation Steps After you have determined what should be included, you will need to know how to write a quality manual. List policies to be written i.

Draft policies based on applicable ISO requirements. List operating procedures or refer to them as appropriate. Including the operating procedure for each process included in your QMS. Determine format and structure of the manual and make the first draft. The format of your quality manual is dependent on your specific needs and company.

Sharp readers will discover at least one acronym in the example QM that is not defined: MRO, which in this case stands for maintenance, repair and overhaul.

If the entire organization operates under the defined quality management system QMS , then there is little need to specifically define the scope. If the QMS applies to only part of an organization, then the scope must be explicitly stated. In the example QM, only the metrology department of the organization is covered by the QMS; the assumption is that the rest of the organization does not have a system that conforms to ISO In the example QM, the scope is defined in section 2.

Ever since ISO was released, there has been much discussion on how big or small the QM should be. Do not try to force it into an arbitrary small number of pages, but do not be overly verbose, either. The QM should be a top-level overview of how the organization operates and does business.

Policies, procedures, work instructions, proprietary information and the like belong in separate documents. While the QM must be reviewed regularly, if a clause or section is changed every time then that part may be a candidate to be pulled out to a separate document.

When deciding what goes into the QM, remember the two main phases of an audit. First, your QM is evaluated against the conformance standard s to make sure all requirements are addressed satisfactorily. Then, your organization's operations and records are evaluated against your QM to verify that you are doing what you say you are doing. In the second phase, anything in your QM is fair game for the auditor to look at.

One advantage of electronic documents is that links to other documents, of any type, can be embedded in the document. In the example QM, links are represented by blue underlined text, but they are simulated. In your real document, each link would actually point to a real document on your file server.

This ability makes control of documents easier. Therefore, whenever someone clicks on the link, they will always — and only — see the current version of the referenced document. The older version can be saved under a different name; the easiest way to do that is to simply add the revision date, in ISO format 2 , to the file name. For example, assume that procedure QP with the revision date of November 10, is being replaced with a new version revised today. No links have to be changed, and the date added to the old version file name uniquely identifies it.

Sharp readers will also note that a version of ISO date format appears in a number of places in the example QM. The date is always written with the biggest time unit year on the left and the smallest time unit day of month for dates on the right. One advantage is that the format is unambiguous and culture-independent.

Another is that a date in this format as part of the file name is always sorted in correct order by a computer. The most common permissible exclusion is clause 7. However, it is generally not a good idea to simply omit the excluded parts from the QM. It is much better to include reference to them, specifically state that they are excluded and why, and what the plans are if the current situation ever changes.

Section 7. In some cases, such as the case of the example QM, the scope of the QMS is so tightly defined that functions normally part of the QMS are actually performed by organizational departments that are outside the defined QMS.

In the case of Mythical True Value Metrology, purchasing is an example of that. The metrology organization only has limited authority for small purchases; all others must go through the corporate purchasing department, which is not part of the QMS. In cases like this, the organization should do two things. First, the QM should describe what they can do, including the limits on it.

The QM should also state that other parts of the parent organization — the parts outside the boundary of the defined QMS — are treated as suppliers or customers, as appropriate. This is shown in section 7.