Table of Contents
What are the key practices of good documentation?
Basic requirements for good documentation practices will include, but not be limited to, the following components:
- Accuracy.
- Data Integrity (protected, secure and backed-up data systems)
- Contemporaneous recordkeeping (timely, immediately/real-time)
- Legible.
What is the key documentation principle for GMP compliance?
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.
What are GxP documents?
What is GxP? GxP is a collection of quality guidelines and regulations created to ensure that bio/pharmaceutical products are safe, meet their intended use, and adhere to quality processes during manufacturing, control, storage, and distribution.
What do you mean by good documentation?
It is the existence of accurate and reliable records that demonstrate that instructions have been followed and, therefore, compliance with GMP regulations. Figure 1: Document types as defined by EU GMP chapter 4.
Why do we need to practice good documentation practices in a workplace?
Documentation is essential to quality and process control There needs to be some level of cohesion so that you don’t look sloppy or uninformed. Documentation encourages knowledge sharing, which empowers your team to understand how processes work and what finished projects typically look like.
What are the benefits of having a good documentation practices?
Leads to a smoother running operation, having complete information and knowing how to properly deal with issues. Reduces documentation errors by having the mechanisms to properly record data and correct errors. Maintains a level of consistency across an organization in how things are documented and recorded.
What do you mean by good documentation practices GDP give some do’s and don’ts of GDP?
Some basic GDP “do’s and don’ts” are listed below….Do’s and don’ts
- Use black or blue permanent, indelible ink.
- Make clear, complete and legible entries.
- Make an entry when an event happens (not later).
- Make corrections that are legible and traceable.
What are Good Laboratory Practice Regulations?
What is GLP (Good Laboratory Practice)? Good laboratory practice or GLP is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies that are intended to support research or marketing permits for products regulated by government agencies.
What are the four important points of documentation?
The four kinds of documentation are:
- learning-oriented tutorials.
- goal-oriented how-to guides.
- understanding-oriented discussions.
- information-oriented reference material.
How can you improve documentation at work?
Dos:
- Do record specific objective and factual information.
- Do follow consistent documentation practices.
- Do reference or include relevant back-up information.
- Do allow for employee acknowledgment and feedback where appropriate.
- Do proofread the document.
- Do sign and date the document.
What is the main purpose of documentation?
The purpose of documentation is to: Describe the use, operation, maintenance, or design of software or hardware through the use of manuals, listings, diagrams, and other hard- or soft-copy written and graphic materials.
What is a GxP compliance checklist?
A GxP compliance checklist can have a positive impact on your organisation. However, to be effective you must first understand the term ‘GxP’ which is an abbreviation for Good Practice. As a phrase, it’s completely vague and tells businesses nothing about how they should be meeting quality guidelines and regulations.
What are goodgood documentation practices (GDocP)?
Good Documentation Practices (GDocP) are central to all GxP Underpinning all GxP, therefore, are the record-keeping and documentation requirements that keep processes trackable and companies fully accountable for the integrity of their data and the quality of their end products. This is referred to by the FDA and others as:
What is the purpose of GXP guidelines?
The purpose of the guidelines is to ensure that the regulated organizations comply with the standard processes of various functions. GxPs are mostly similar across all the countries. The guidelines mainly focus on the following areas: Traceability – ensuring that the development history of the product can be reverse engineered.
What are my GDocP and GXP training responsibilities?
Your GDocP and GxP training responsibilities include everyone in your production and transportation chains when you distribute (ship and deliver) your products to various warehouses, chemists/pharmacies or other clients.