GMP and GLP standards


Good Manufacturing Practices (GMP)

GMP are the practices required in order to conform to the guidelines recommended by agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical or a food product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.

All guidelines follow a few basic principles:

  • Manufacturing facilities must maintain a clean and hygienic manufacturing area.
  • Controlled environmental conditions in order to prevent cross contamination of food or drug product from adulterants that may render the product unsafe for human consumption.
  • Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
  • Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that affect the quality of the drug are validated as necessary.
  • Instructions and procedures are written in clear and unambiguous language. (Good Documentation Practices)
  • Operators are trained to carry out and document procedures.
  • Cross contamination with unlabelled major allergens is prevented.
  • Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the food or drug was as expected. Deviations are investigated and documented.
  • Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.
  • The distribution of the food or drugs minimizes any risk to their quality.
  • A system is available for recalling any batch from sale or supply.
  • Complaints about marketed products are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective products and to prevent recurrence.

 

Products of Achem Pharmaceuticals have been succesfully tested by Simec Analytics laboratory in compliance with GMP standard.

Avaliable test reports for:

Achemabol 10 mg

Primachem 100 mg/mL

Testachem С 200 mg/mL 

Testachem E 250 mg/mL

 

 

Good Laboratory Practices (GLP)

GLP is a quality system concerned with the organizational process and conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.

GLP applies to non-clinical studies conducted for the assessment of the safety or efficacy of chemicals (including pharmaceuticals) to man, animals and the environment.

GLP principles include:

  • Organization and Personnel.
  • Quality assurance program.
  • Facilities.
  • Equipment, reagents and Materials.
  • Test systems.
  • Test and Reference items.
  • Standard operating procedures.
  • Performance of Study.
  • Reporting of results.
  • Archival – Storage of Records and Reports.

Products of Achem Pharmaceuticals have been succesfully tested by Janoshik Analytical laboratory in compliance with GLP standard.

Avaliable test reports can be checked here:
Clenachem
Boldenachem
Testachem P
Sustachem