Good Documentation Practices. By Mr.Vikram Joshi [email protected] “ 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: - .
By Mr.Vikram Joshi
“ 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”.
To Document each Activity you perform
Is it True ?
To design an effective & efficient documentation process first identify the important characteristics of processing event.
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”
Authorized document review and approval signatures are responsible for directing the manufacturing, the security, original, approved documents is the responsibility of QA.
Responsibility of all technicians, engineers, scientists, operating persons who are trained and authorized to collect and record data
Responsibility of suppervisors, managers and all individuals trained & authorized to review data
Responsibility of QA or those trained & authorized to review records
Records are Accessible, Retrievable, Secure is the responsibility of QA & relevant departments
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.
Your documentation is an advertisement for your work.
WHY DOCUMENTATION ?
Cost for Good
Cost for Poor/No
THEREFORE, DOCUMENTATION BRINGS BUSINESS
WHERE DOCUMENTATION ?
There are three types of Documents
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BPRs are the first major Exhibits reviewed by FDA
The documentation process defines the relationship between the corporation and regulatory authorities. (Commitment Documents)
Note:- More Control does not necessarily lead to greater order or more security.
Note: - This is a fundamental quality assurance requirement for the processing of documents
MPR Firmed up on the basis of Dev. 000 MPR effective
Draft MPR attached as Annexure – I.
Errors in manual entries in various documents shall be rectified in blue ink as follows :