What are examples of good documentation practices?

For Beginners | GMP Basics for Good Documentation Practices

• data accuracy. recorded accurately.
• data integrity/validation. genuine, true data.
• reporting/record-keeping timeliness. information is recorded contemporaneously.
• legibility. clarity.
• identifiable. clear records that can identify the person who actually records the data.

What are potential consequences of getting documentation practices wrong?

Inadequate and poor documentation practices may result citations in the form of FDA’s 483 observation(s) and/or warning letters. Consequences of both may be time consuming and costly including time spent in responding to the observations and potentially making some operational changes.

Why is it important to follow good documentation practices?

Good documentation practices helps to track changes, ensures easy reporting of any defects as well as promote continuous improvements to the processes that can be recorded real time.

What is good documentation process?

Good documentation practice GDP is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of documents. The importance of documentation: As per GMP documentation control “If it is not written down, then it did not happen”.

What are the 5 main components of good manufacturing practice?

To simplify this, GMP helps to ensure the consistent quality and safety of products by focusing attention on five key elements, which are often referred to as the 5 P’s of GMP—people, premises, processes, products and procedures (or paperwork).

What is GMP documentation?

Documentation is the key to GMP compliance and ensures traceability of all development, manufacturing, and testing activities. Documentation provides the route for auditors to assess the overall quality of operations within a company and the final product.

What are GMP violations?

Some common GMP violations include: Inadequate identification (i.e. analytical verification) of incoming ingredients. Lack of set Master Manufacturing Records (MMRs) Ineffective finished product testing. Failure to implement and follow written procedures.

What are CGMP documents?

The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.

What are 5 P’s of GMP?

What is required for GMP documentation?

Documents must be approved, signed, and dated by the appropriate competent and authorized persons. Documents must have unambiguous contents. The title, nature, and purpose should be clearly stated. They must be laid out in an orderly fashion and be easy to check.