GxP Good Practice
The principles of Good Practices (GxP) are the guidelines and standards of the Good Practices. The “x” represents a field in particular: Clinical (GCP), manufacturing (GMP), distribution (GDP), laboratory (GLP), and agriculture (GAP), etc.
SHAPYPRO advise you on how to fulfill the requeriments of the Good Practices in your field, guiding you through all the process through audits, fluid communication and elimination of the bad habits.
Good Manufacturing Practice (GMP)
The Good Manufacturing Practices GMP are fundamental since they responsible for the assurance that the products are manufacturing and controlling according to the quality standards established by the health authorities. SHAPYPRO team can help you with the development and evaluation of GMP for different industries such as:
- Food industry
- Cosmetics according to EN-ISO 22716
- Pharmaceutical industry
Good Laboratory Practice (GLP)
The principles of Good Laboratory Practice (GLP) are applied in the performance of tests to obtain data about the properties and hazards for people, animals and the environment of any chemical substance. The purpose of these tests is to submit the substances studied to the regulatory authorities responsible for their official registration prior to their incorporation into the market.
The tests covered by GLP are classified into four categories based on their purpose:
- Physico-chemical properties.
- Toxicological studies, designed to assess effects on human health.
- Ecotoxicology studies on aquatic or terrestrial organisms: designed to assess effects on the environment.
- Ecological studies on behaviour in water, soil and air, or bioaccumulation: designed to assess environmental destination and performance.
Good Clinical Practice GCP
The Good Clinical Practice (GCP) guide is an international standard of ethical and scientific quality applicable to the design, performance, registration and communication of clinical trials in which human beings participate. Compliance with this standard provides a public guarantee of the protection of the rights, safety and well-being of the trial subjects in accordance with the principles of the Declaration of Helsinki, as well as guarantees the credibility of the clinical trial data.
SHAPYPRO will help you to comply the following points:
- Responsibilities and delegations.
- Approval documentation.
- Study protocol and amendments.
- Receipt and control of drug dispensing.
- Compliance with the protocol at all times.
- Review of the information process and informed consent documents.
- Verification of original data.
- Reporting of Adverse Reactions (AR).
- Archiving of study documents.
- Computer System Validation.
SHAPYPRO provides you professional consulting and management services for all your laboratories, helping you to train qualified professionals, obtain extensive and correct knowledge of the analysis methods for hazardous substances required by different countries in addition to establish comprehensive laboratory management systems.
SHAPYPRO does not offer preparation services for the certification of management systems. All consulting activities provided by SHAPYPRO are independent from certification/accreditation activities.