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Documentation & Importance By Mr. Ramesh Reddy


DOCUMENTS: - Quality can not be assured in a regulated industry without good documents and good documentation practices A document system is an interdependent, interrelated set of documents, each with a defined purpose and a consistent format. Documentation is a process that involves the systematic interaction of people, events and documents to create the records of the organization / corporation.


PURPOSE OF DOCUMENT SYSTEM No matter what type of product is developed and produced, it must be safe, effective and fit for its intended use. Quality characteristics are established in documents. Documents declare product standards and describe how to monitor, test and judge for compliance with these standards.


DOCUMENT SYSTEM BASICS A document system is an interacting set of documents, each with a defined purpose and consistent document. The documents can: Assure that quality standards are consistently met Communicate these standards to all who interact with product Interact in a manner that reduce redundancy and increase the flexibility of the system when changes occur


A DOCUMENT SYSTEM OF YOUR OWN The types of documents, number of documents and the level of detail in documents will vary from company to company depending on the following: The type of product (its classification of risk) The unique nature of the product, the product delivery system or the manufacturing process The size of the company The education and training of the employees How much the company does (Develops, manufactures, packages, distributes products)

What is Documentation:

What is Documentation The information provided by a creator which provides enough information to establish basis, history and context and to enable its use by others. It needs to be sufficiently detailed to allow the data creator to use the material in the future, when the data creation process has started to fade from memory. It also needs to be comprehensive enough to enable others to explore the resource fully, and detailed enough to allow someone who has not been involved in the data creation process to understand the data collection and the process by which it was created."

Good Documentation Practices:

Good Documentation Practices Key documents with the potential to impact product quality must be retained to provide a traceable, historical record of all activities. Documentation must be readily retrievable in order to meet requirements associated with product investigations, periodic product review, or formal audits It is necessary to document anything that directly impacts a product. Record every procedure you write, form you fill out, and test you perform.


ESSENTIAL CHARACTERISTICS The document directing the manufacturing event fulfills current regulatory commitments to the agency; it is appropriately written, reviewed and approved The directive document is appropriate for the task to be performed The data is accurate The data is complete. There is no missing information, and there is no work as yet uncompleted that will impact the occurrence of the data presented. To design an effective & efficient documentation process first identify the important characteristics of processing event.


ESSENTIAL CHARACTERISTICS The data is legible, consistently recorded and trustworthy The data collected fulfills expectations (specifications) The data is accessible to those who need to review it, audit it or use it to perform trending analysis. The original data and the original documents (manufacturing record) is retrievable for review or audit The original manufacturing record is secure Proper control of documentation also requires that responsibility for each processing step to be assigned

Why Documentation:

Why Documentation There is a saying in the pharmaceutical industry: 'if it hasn't been documented, then it hasn't happened!' Good documentation practice constitutes an essential part of the QA system. Documentation system must be proactive vehicle of communication. Your documentation is an advertisement for your work .

PowerPoint Presentation:

WHERE DOCUMENTATION ? Documentation during Project Design, Documentation during Construction Phase , Documentation during Commissioning and start-up , Documentation during Qualification and Validations Documentation during Commercial Production, Documentation during Testing and Release, Documentation for Regulatory submissions .

Types of Documents:

Types of Documents There are three types of Documents Commitment Documents : Relationship between industry and the regulatory authorities Directive Documents : Relationship between the Management and Employees Record Documents : Relationship between the Employees and the Work they perform

Some Examples are ::

Some Examples are : Commitment Documents : New Drug Applications (NDAs), Drug Master Files (DMFs) etc. Directive Documents : Specifications, STPs, SOPs, MPRs etc. Record Documents : Protocols, BPRs, Log Books, Calibration Records etc.


COMMITMENT DOCUMENTS Presents corporate goals, expectations and standard of practice Consensus of purpose, direction and authorization for projects Organize the work in a manner that assures efficient and effective work flow These documents such as master plans; organize and prioritize the work in a manner that supports good business practice as well as regulatory compliance


COMMITMENT DOCUMENTS Written to lead and guide the work and workers To be used as active documents that are consulted and followed routinely Content must be consistent and rigorous in order to lead and guide the work and the workers Deviations from regulatory submissions can have signification impact on product quality Any deviation must be documented and managed


DIRECTIVE DOCUMENTS Working documents that establish the standards for resources, processing, products & quality system Describe how to do it……??? Describe how to do routine work The different types are determined by the specific, functional purpose of the document in the document system In order to facilitate the development, production, testing and distribution of a product in a defined manner Reviewed and approved by both management and the individuals responsible for performing the work

What Good Documentation requires ::

What Good Documentation requires : APPROVAL - this applies particularly to work instructions, procedures, manufacturing formulae and specifications. Approval should be by the relevant technical, management and quality personnel, to ensure that documents comply with the principles of GMP and the specific product marketing and manufacturing authorisations

What Good Documentation requires ::

What Good Documentation requires : CLARITY - they should not be open to misinterpretation by the users. They should be written in a way that makes them easy to check, particularly when they will form part of a product manufacturing history. Good documentation design will help to minimize errors

What Good Documentation requires ::

What Good Documentation requires : REGULAR REVIEW AND UPDATE - documents must be kept up-to-date with changes in regulations or processes and should be distributed in a controlled manner to ensure that only the most recent versions are available for use. They must also be available to those who need them, where they need them!

What Good Documentation requires ::

What Good Documentation requires : FORMAL PRESENTATION - controlled documents should be prepared in accordance with a written procedure, now a days probably using a computerized documentation control system.

What Good Documentation requires ::

What Good Documentation requires : Records should be made at the time of each action - do not rely on memory for their completion. Records relating to manufacturing or testing operations should be kept for at least one year after their expiry.

What Good Documentation requires ::

What Good Documentation requires : If documents or data are stored electronically, the computer system must be validated to assure data security and integrity. Provisions must also be made to retrieve the stored data, possibly years after they have been generated:

What are Major Documents:

What are Major Documents CCIFs Failure Investigation & Reports Planned & Unplanned Deviation Reports Filling of BPRs APRs Validation Protocols & Reports Raw Data & proper Recording Log Sheets Sketches - Diagrams Plant Development Reports Engineering Documents


DOCUMENTATION: PROCESSING & CONTROL The documentation process defines the relationship between the corporation and regulatory authorities. (Commitment Documents) Corporate management and the workers (Directive Documents) The workers and the work that they perform The record of the events directed in directive documents is evidence Records can be used as evidence against a company by FDA- in court


DOCUMENTATION: PROCESSING & CONTROL Evidence can be used by a company to defend it self in court The quality of the documents can be directly and adversely affected by the quality of the document processing procedures that directs creation, review, approval, distribution, change and archiving of documents Every person must be trained to complete documents properly; improper use of the documents can lead to inaccurate, inadequate or incomplete documents


DOCUMENT PROCESSING PROCEDURES TO BE SURVEYED Why are delays occurring? Is there redundancy in the system? Do records disappear? Are documents inconsistently completed? Has the product been released with records missing? Note:- More Control does not necessarily lead to greater order or more security.

List of concerns when designing documented processing control: -:

List of concerns when designing documented processing control: - When documents or records are transferred from one department to another or from one building to another the transfer should be recorded When documents or records are waiting to be processed, they should always be stored in designated location. Apply the same principles to the security of documents during review process

PowerPoint Presentation:

Records must always be completely identified and this identity should be consistent and easily available. Every page of every document should be consistently labeled with the document identification number/ code, the document revision number/code, the product identification number / code and product lot number. Every signature associated with document review and approval should add value to the document Every one who signs a document or record should know what their signatures means

PowerPoint Presentation:

Only those individuals trained and authorized to sign documents should sign them It remains a challenge in normal systems to know who is trained and authorized to sign what document Note: - This is a fundamental quality assurance requirement for the processing of documents Databases should be qualified or validated There should be procedure in place to direct the data entry process


SUMMARY Documentation must be consistent and systematic Documentation practices must assure that records meet GMP requirements Documentation process must be controlled to minimize redundancies in the work flow

Tips of Good Documentation:

Tips of Good Documentation Each entry in the record shall be legible (readable) and be written in blue ink. Never use Pencil, Correction Fluid, Eraser etc. No page or column shall remain blank/ unfilled. NA shall be entered. All records/documents are maintained in a presentable manner.

Tips of Good Documentation:

Tips of Good Documentation Errors in manual entries in various documents shall be rectified in blue ink as follows : . MPR Firmed up on the basis of Dev. 000 MPR effective 01.07.2004. Draft MPR attached as Annexure – I. 001 08.09.2004 Wrongly mentioned as 000.



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