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2. ? 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?.
3. 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.
4. PURPOSE OF DOCUMENT SYSTEM ?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.
5. BASIC REQUIREMENTS FOR ASSURING THE QUALITY 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
6. BASIC REQUIREMENTS FOR ASSURING THE QUALITY Manage Charge:
Recording the change and providing appropriate rationale in writing for that change
Have written evidence of the established quality standards, of the maintenance and monitoring programs, of the monitoring data and of any changes that occur
7. 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
8. 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)
Keep the expectations in corporate documents simple and relevant, make them your own
9. What is Documentation ?
10. What is Documentation
11. Good Documentation Practices
12. 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 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.
13. 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?
14. DOCUMENTATION LIFE CYCLE 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
15. DOCUMENTATION LIFE CYCLE Record 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.
16. Why Documentation
18. Here are some selected GDP references from 21CFR58: 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.
20. Types of Documents
21. Some Examples are :
22. 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
23. 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
24. 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
25. What Good Documentation requires :
26. What Good Documentation requires :
27. What Good Documentation requires :
28. What Good Documentation requires :
29. What Good Documentation requires :
30. What Good Documentation requires :
31. Strengths of Good Documentation
32. Strengths of Good Documentation
33. What are our Major Documents
36. Filling of BPR
37. 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
38. 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
39. The Resources and raw materials of the documentation processes are as 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
40. 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 The Resources and raw materials of the documentation processes are as follows:-
41. Controls are either industry standard or corporate ?based controls that help assure efficient and effective processing.
42. 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.
43. Following is a 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
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
44. 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
45. 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
46. Here are some selected GDP references from 21CFR211: 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.
47. Example of typical guidelines found in Good DocumentationPractices/Recordkeeping procedures: 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 "whiteout" 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.
48. 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. Example of typical guidelines found in Good DocumentationPractices/Recordkeeping procedures:
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. Example of typical guidelines found in Good DocumentationPractices/Recordkeeping procedures:
50. 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
51. Tips of Good Documentation
52. Tips of Good Documentation
55. Always to remember