Document:
It has been said that in the pharmaceutical industry, “If it isn’t documented, it didn’t happen” Therefore, in the pharmaceutical and medical device industry, we document to provide written proof that something happened.
Records and reports, along with procedures, "tell the story" of manufactured products and devices. In addition to regulatory requirements, it is also very important to maintain accurate records for business reasons. By maintaining clear, accurate and timely records you can take a critical look at various processes related to product manufacture with the intent of making quality, product or cost saving improvements.
Purpose of good Documentations Practice:
- Defines specifications and procedures for all materials and methods of manufacture and control
- Ensures all personnel know what to do and when to do it
- Ensure that authorized persons have all information necessary for release of product
- Ensures documented evidence, traceability, provide records and audit trail for investigation
- Ensures availability of data for validation, review and statistical analysis.
GDPs apply to everyone who documents activities related to cGMP or current Good Manufacturing Practices.
Compliance with the Food and Drug Administration's GLP, or Good Laboratory Practices, regulations (21 CFR Part 58), as well as GMP regulations for drugs and medical devices (21 CFR Parts 211 and 820) requires the use of Good Documentation Practices.
GDPs are enforced by regulatory agencies such as the FDA, TGA, EMEA, Health Canada or WHO.
Why Us?
Making a document takes a lot of precious time of your technical staff. To help you
overcome your problem
Rutika lifesciences has come forward. We can check your document & help you improve
them. We can also
provide you ready made documents, also documents with the name of your company, your
machine, your products,
your Chemist name etc. so that you have to just sign & the record is ready.
1.Quality Control Documents
The document is critical factor for good laboratory practice. Documentation is accepted method of recording information for future reference. The major factors that need to be provide are Specification, protocols, logbook that are usages maintenance and calibration of equipment’s there should be well established SOP’s .
2.Production Documents
Documentation is an integral part of good manufacturing practices. It defines a system of information and control so that risks so inherent in misinterpretation and/or error in oral communication are minimized. It consequently strengthens the quality, and its consistency, of all goods and services, as those responsible for the specific operations have clear, unambiguous instructions to follow including active drug substances, is legally mandatory.
3.Quality Assurance
Quality Assurance is an important part of pharmaceutical manufacturing. It assures the quality of the products those are manufactured in manufacturing facility. It is thought that documentation is the main function of quality assurance but it also controls the manufacturing system to manufacture the quality products.
4.Regulatory affairs
Regulatory Affairs is the knowledge and application of strategic and operational enforcement of the legal frame work concerning pharmaceuticals and related products in a national and global perspective. Regulatory Affairs plays a crucial role in the pharmaceutical industry and is involved in all stages of drug development and also after drug approval and marketing. Pharmaceutical companies use all the data accumulated during discovery and development stages in order to register the drug and thus market the drug.
5.Pharma Audit Documents
Review Documents: A list of all documents related to the audit should be prepared. Documents may include batch manufacturing records, master formula records, standard operating procedures, the method of analysis, deviations, change controls, stability testing data etc.