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Quality is never an accident, it is the result of high intention, sincere effort, intelligent direction and skillful execution. It represents the wisest of many alternatives.
DOCUMENTS:
As discrete packages of recorded information are the tools of quality assurance. Used to establish standard specification and processes that assures compliance with standard specifications and processes 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.
Each manufacturer shall establish effective quality system, instructions and procedures in accordance with the requirements of this part and maintain the established quality system instructions and procedures effectively. 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.
Establish the quality. Determine which attributes of the resources, process or product are critical to product use or performance. Chose quality parameters and test methods that are scientifically rigorous and then document them Maintain the Quality / Monitor the quality Established quality system parameters to be met routinely and asssure control is effective
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
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) Keep the expectations in corporate documents simple and relevant, make them your own
What is Documentation ?
To Document each Activity you perform
No, Documentation is a Process, Which comprises of Following : Recording of Data Review of Documents Approval of Documents Issuance and Disposal of Documents Retrievability of Documents Presentation of Documents
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."
ESSENTIAL CHARACTERISTICS
To design an effective & efficient documentation process first identify the important characteristics of processing event.
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 authentic; the individual responsible for performing the work has entered the data on an appropriate data collection document 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.
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 All documentation should be legible, clean, readily identifiable, retrievable and maintained in facilities that provide a suitable environment to minimize deterioration or damage and to prevent loss
Document creation, Review Approval: Authorized document review and approval signatures are responsible for directing the manufacturing, the security, original, approved documents is the responsibility of QA. Document use & Data collection: Responsibility of all technicians, engineers, scientists, operating persons who are trained and authorized to collect and record data Data Verification: Responsibility of suppervisors, managers and all individuals trained & authorized to review data Record Review & Product disposition / Approval: Responsibility of QA or those trained & authorized to review records
Record Achieving:Achieving:Records are Accessible, Retrievable, Secure is the responsibility of QA & relevant departments Record Destruction: As per SOPs that directs the destruction of documents Every signature associated with documents review & approval, data collection and record review and approval should add value to the document. Every one who signs a document or a record should know what their signature means. Only those individuals trained and authorized to sign documents should sign them.
Why Documentation
There is a saying in the pharmaceutical
WHY DOCUMENTATION ?
All data generated during the conduct of a study, except those that are generated by automated data collection systems, shall be recorded directly, promptly, and legibly in ink. All data entries shall be dated on the date of entry and signed or initialed by the person entering the data. Any change in entries shall be made so as not to obscure the original entry, shall indicate the reason for such change, and shall be dated and signed or identified at the time of the change.
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. Documentation beyond...
Types of Documents
There are three types of Documents
Commitment Documents : Relationship
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 Several types of directive documents 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
COMMITMENT DOCUMENTS
Presents corporate goals, expectations and standard of practice Describes what to do Consensus of purpose, direction and authorization for projects Organize the work in a manner that assures efficient and effective work flow Commitments documents can also be written to establish internal commitments. 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 Must describe the work as it will be done Deviations from regulatory submissions can have signification impact on product quality Any deviation must be documented and managed
management and quality personnel, to ensure that documents comply with the principles of GMP and the specific product marketing and manufacturing authorisations
minimize errors
operations should be kept for at least one year after their expiry.
electronically, the computer system must be validated to assure data security and integrity.
Provisions must also be made to retrieve the
CCIFs
Incomplete Forms / columns Justification for change not in line with the
OOS
Many OOS Results unreported, therefore
no investigations
Investigations not thoroughly performed Investigation should lead to assignable
result(s)
Filling of BPR
Missing signatures & dates Over-writing without correction, sign, date No remarks for correction Control Number not recorded correctly Time/Date and PC Number recorded in BPR not matching with in-process production Log Books
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
The Resources and raw materials of the documentation processes are as follows:follows: Directive documents that provide instructions Data collection documents that provide a format for data collection Data or information observed or collected from processing events Operating personals or scientists who have been trained to follow instruction and collect data Quality of these resources and materials must be assured These resources / raw materials interact in a systematic manner Data is collected according to an established process
The Resources and raw materials of the documentation processes are as follows:follows: To produce the final product data document Quality of interaction of these resources that can have the greatest impact on the quality of final documentation Proper design and control of this documentation process is essential Many things that can go wrong, when moving hundreds of documents through the documentation process Process controls are added to assure the integrity and reliability of the documentation process
Controlled, Documented issue of production batch records. Verification of laboratory test data for Accuracy, Completeness compliance with established standards
Controls are either industry standard or corporate based controls that help assure efficient and effective processing.
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:Note:- More Control does not necessarily lead to greater order or more security.
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 Critical processing steps should be checked include document issue, data collection, document review. More review signatures on a document does not necessarily result in a more through review
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
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
To assure uniformity from batch to batch, master production and control records for each drug product, including each batch size thereof, shall be prepared, dated, and signed (full signature, handwritten) by one person and independently checked, dated, and signed by a second person. An accurate reproduction of the appropriate master production or control record, checked for accuracy, dated, and signed; The initials or signature of the person who performs each test and the date (s) the tests were performed... The initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness, and compliance with established standards... Complete records shall be maintained of any modification of an established method employed in testing. Such records shall include the reason for the modification and data to verify that the modification produced results that are at least as accurate and reliable for the material being tested as the established method.
All entries must be clear and legible Never make erasures or writeovers. Any written error must be crossed out in such a manner that the original information is still legible. Do not scribble out or "white out" entries. Thus, the integrity of the record will not be in question. The crossed out section must be initialed and dated by originator. Corrections must be made adjacent to the deleted entry. Data may be attached to the page, however, it must be firmly attached. Label, sign and date the attachment. The location of the attachment in the record is indicated with "bridging". Approved methods of bridging are cross hatching or signing across the edge of the attachment and page.
When portions of a page or a complete page remain unused, a single line must be drawn angularly across the unused portion. Sign and date the crossed out section and provide an explanation when necessary. This is not applicable to blank portions on preprinted documents such as MBRs. Use only black or blue permanent ink. The ink should not run or smear if the record is splashed with liquid. Pencil is not acceptable, since all entries must be permanent and able to be photocopied. Make the required entries on the record as the work is performed. Do not record information on a separate piece of paper and enter on the record later All planned and unplanned deviations from the approved production procedure or testing/inspection plan as described in GMP controlled documentation must be documented using a Discrepancy Report. The DR# should be indicated in the record at the location of the change.
Use correct rounding off procedures and significant figures When a comment or explanation is required, make all statements objective. Avoid personal comments and opinions. When dating a signature, use the actual day the signature was signed. If the activity being recorded occurs on more than one day, the record must clearly indicate where the "break" occurred. This can be accomplished by drawing a horizontal line through the procedure at the break" and indicating the new date or making entries that are initiated and dated appropriately. If a record becomes messy and extremely difficult to read, do not discard. Consult supervisor prior to transcribing the data to a clean record sheet and attaching the original record sheet. Provide an explanation for the transcription.
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
001 08.09.2004 MPR Firmed up on the basis of Dev. 000 MPR effective 01.07.2004. Draft MPR attached as Annexure I. .
Learnings.
Good Documentation Practices should be everyones concern. Foundation of a sound documentation system begins with the engineering documents as well as their management. Engineering is the provider Production is the customer QA is the gatekeeper. Validation is the hold-up and Everyone just wants to pass the baton.
Learning
More entries we make, the greater the opportunity for error. But, if we reduce the documentation, we may omit critical and vital data.
Any activity becomes creative, if the Doer cares about doing it right or better. Each Activity is a forward Certification if performed with proper perspective and documented in a right way.
Always to remember
Truly, documentation is our Business, and to remain profitable, we should forget the syndrome We can fix the documentation later ........
Thanks