Federal Regulatory Support: GMP & GLP
Good Manufacturing Practices (GMP) & Current Good Manufacturing Practices (cGMP)
GMP compliance is required by OECD countries and cGMP is required by the U.S.
FDA to ensure that proper guidelines are followed in the manufacturing of active
pharmaceutical ingredients (APIs), finished drug formulations,
animal drugs,
dietary supplements, food, food additives and
medical devices.
TSG
assists in the following aspects of GMP/cGMP compliance:
Manufacture
Audit – Based on the needs of the client, TSG will visit a manufacturer’s
facility and meet with the company’s technical representatives to review
existing GMP or cGMP documentation and the manufacturer’s current compliance
with these requirements. TSG will then provide a written auditing report to the
clients.
Assisting
Manufacturers to Establish GMP/cGMP Compliance – Based on the needs of the
client, TSG will conduct a facility evaluation (materials and process
documentation, quality control, stability testing, product and label control)
and review existing Standard Operating Procedures (SOPs) for compliance with
international standards. TSG will then identify additional SOPs subject to
compliance, assist in writing additional SOPs and conduct onsite GMP/cGMP
orientation and training for the facility. TSG will follow-up with detailed
documentation on the facility, proceed to establish quality control mechanism
and oversee the completion of documents and GMP/cGMP program requirements.
After
this process is completed, TSG will conduct a facility audit to ensure
GMP/cGMP compliance. This includes a production line and facility
inspection, laboratory inspection, raw data audit and QA documentation
audit. TSG will finalize the audit by preparing a report and discussing the
findings with the company’s technical representatives and management.
Good Laboratory Practices (GLP)
GLP compliance is required for studies submitted in
support of product approvals with
pesticides,
new chemicals and petitions to
establish maximum residue levels (MRLs) for EPA, PMRA and the EU, as well as
pharmaceuticals, animal drugs and medical devices for FDA and the EU.
TSG assists in the following aspects of GLP compliance:
Laboratory Audit
– Based on the needs of the client, TSG will visit a
laboratory
facility and meet with the technical, management and quality assurance
personnel to review existing GLP documentation and the current compliance
with the GLP requirements. TSG will then provide a written auditing report
to the client.
Assisting Laboratories to Establish GLP Compliance
– Based on the needs of the client, TSG will conduct a laboratory evaluation
(personnel training and records, materials and experimental or analytical
documentation, quality assurance and more) and review existing SOPs for
compliance with international standards. TSG will then identify additional
SOPs subject to compliance, assist in writing additional SOPs and conduct
onsite GLP orientation and training for the facility. TSG will follow-up
with detailed documentation on the facility, proceed to establish Quality
Assurance (QA) mechanism and oversee the completion of documents and GLP
program requirements.
After this process is completed, TSG will
conduct a laboratory facility audit to ensure GLP compliance. This includes
inspection of all relevant laboratories and facilities, inspection of sample
collection, preparation and storage procedures, inspection of analytical
procedure and raw data audit, as well as a QA documentation audit. TSG will
finalize the audit by preparing a report to discuss the findings with
laboratory technical representatives, management staff and QA unit.
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