GxP Solutions is a privately-held, Toronto-based consulting corporation serving the pharmaceutical and biotech industries. The client is our primary focus. We take a collaborative approach on every initiative, delivering high quality, customized solutions consistent with your corporate culture and the ever-evolving regulatory environment.
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Definition of GxP
GxP is the abbreviation for Good – x – Practices. GxP is based on regulations and guidelines for the pharmaceutical industry. The “X” can represent Manufacturing, Clinical, Laboratory, Documentation, Distribution or Warehousing, etc.
Good Manufacturing Practices (GMP) is a quality system for ensuring that products are consistently produced and controlled according to quality standards appropriate to their intended use, as required by the marketing authorization . It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
Good Laboratory Practices (GLP) is a quality system concerned with the organisational process and conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.
Good Clinical Practices (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects. Regardless of whether a clinical trial is a large, multi-centre study in patients or a small clinical pharmacological study in healthy subjects, the relevant GCP standards should be followed by the sponsoring company of the healthcare product, the investigators, the ethics committees and any clinical research organizations.
Good Warehouse Practices (GWP) are the best practices that correspond to warehousing that cover the following areas:
- Premises
- Security
- Temperature and humidity control
- Equipment
- Personnel
- Sanitation
- Receipt of incoming goods
- Assembling orders and issuing goods
- Packing for transportation
- Transport
Good Distribution Practices (GDP) deals with the guidelines for the proper distribution of medicinal products for human use. GDP is a quality warranty system, which includes requirements for purchase, receiving, storage and export of drugs intended for human consumption. GDP regulates the division and movement of pharmaceutical products from the premises of the manufacturer of medicinal products, or another central point, to the end user thereof, or to an intermediate point by means of various transport methods, via various storage and/or health establishments.
Good Documentation Practices (GDP) enables communications of intent and consistency of actions. The purposes of Good Documentation are:
- To define the specifications and procedures for all materials and methods of manufacture and control;
- To ensure that all personnel concerned with manufacturing know what, when and how to manufacture products consistently;
- To ensure that authorized persons have all the information necessary to decide whether or not to release a batch of a drug for sale;
- To ensure the existence of documented evidence, traceability, and to provide records which provide an audit trail that will permit investigation;
- To ensure the availability of the data needed for validation, review, and statistical analysis.
The following are the types of documents, which organization should establish and keep:
- Guidelines to provides recommended practices and instructions.
- Policies that establish the organization interpretation and attitude toward the regulatory body.
- Standard Operating Procedures (SOPs) provide detailed instructions on how to implement a process or perform a specific activity.
- Records that document results achieved or providing evidence of activities performed.
- Forms and Templates which are pre-structured documents with blank spaces designed for insertion of required information.
- Manuals that provide information on how a system or equipment operate.
Good Pharmacovigilance Practices (GPV) are the regulatory requirements for manufacturers, including but not limited to, the reporting of Adverse Drug Reactions (ADRs) and the reporting of unusual failures in efficacy of new drugs to Health Authorities.