What is the purpose of GCP?
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. It also serves to protect the rights, integrity and confidentiality of trial subjects.
When is GCP required?
All investigators and staff who are involved in the conduct, oversight or management of NIH funded clinical trials are required to complete training in Good Clinical Practice (GCP) and refresh this training every 3 years, consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2) .
What is pharma investigation?
Investigation is the process of. collecting and analyzing data to determine the cause of non- compliance or failure. In pharmaceutical industry, failure or. non-conformity may arise due to any of the following reasons.
What is full form of ICH?
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines.
What is ICH Q10?
ICH Q10 is a model. for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle. Much of the content of ICH Q10 applicable to manufacturing sites is currently specified by regional GMP requirements.
What are the four categories of ICH guidelines?
The ICH topics are divided into the four categories below and ICH topic codes are assigned according to these categories.
- Quality Guidelines.
- Safety Guidelines.
- Efficacy Guidelines.
- Multidisciplinary Guidelines.
How many types of ICH guidelines are there?
The ICH topics are divided into four categories and ICH topic codes are assigned according to these categories: Q : Quality Guidelines. S : Safety Guidelines. E : Efficacy Guidelines.
What are the responsibilities of a principal investigator?
Principal Investigator (PI) – A Principal Investigator is the primary individual responsible for the preparation, conduct, and administration of a research grant, cooperative agreement, training or public service project, contract, or other sponsored project in compliance with applicable laws and regulations and …
What are the principles of GMP?
The most compliant principles of GMP include (1) designing and constructing the facilities and equipment properly and identifying the responsibilities; (2) following written procedures and instructions; (3) documenting work; (4) validating the processes and evaluating the staff performances; (5) monitoring and regular ..
What is ICH Q7 guidelines?
The ICH guidance Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality.
What is the major cause of OOS?
Test Analysis Error in QC Lab: Error in the QC lab is human or analyst error. This is the most probable cause of the OOS and should be investigated first during the investigation of OOS. There are many areas where errors may possible.
How do you do an OOS investigation?
Investigation of out of specification results
- Tests were performed under prescribed environmental conditions.
- Tests were conducted by a validated analyst.
- Whether validated test methods were adopted and SOP is followed without deviations.
- Equipment and glassware used were calibrated.
- Reagents used were within their validity.
What is deviation and types?
It means deviation from any written procedure that we have implemented. Now deviation can be of two different types: A) Planned Deviation B) Unplanned Deviation. Planned deviations are those deviations from the procedure that are planned and we know before they occur.
Who are the members of ICH?
- ANVISA, Brazil.
- HSA, Singapore.
- MFDS, Republic of Korea.
- NMPA, China.
- TITCK, Turkey.
- TFDA, Chinese Taipei.
What are OOS?
Out of specification (OOS) is defined as a result that falls outside the predetermined specifications or established acceptance criteria set by the manufacturer and/or the laboratory. Similarly, out of trend (OOT) is defined as a result that falls outside the trend.
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).
WHO guideline GMP?
Good manufacturing practice (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.
What is ICH Q?
Guideline. Q1B Guideline. Q1CStability Testing for New Dosage Forms. The ICH Harmonised Guideline was finalised under Step 4 in November 1996. It extends the main stability Guideline for new formulations of already approved medicines, and defines the circumstances under which reduced stability data can be accepted.
What is OOS and OOT?
Out of Trend (OOT): The test results that may be within specification but show significant. variation from the historical results. OOS (out of specification) is the comparison of one result versus predetermined specification. criteria while OOT (Out of Trend) is the comparison of many historical data values versus time …
How do you handle oos and Ocarina of Time?
1. OOS (out of specification) is the comparison of one result versus predetermined specification criteria while OOT (Out of Trend) is the comparison of many historical data values versus time.
What are the safety guidelines as per ICH?
Stakeholders are invited to report Safety Guideline issues at [email protected]
- S1A – S1C Carcinogenicity Studies.
- S2 Genotoxicity Studies.
- S3A – S3B Toxicokinetics and Pharmacokinetics.
- S4 Toxicity Testing.
- S5 Reproductive Toxicology.
- S6 Biotechnological Products.
- S7A – S7B Pharmacology Studies.
- S8 Immunotoxicology Studies.