Audits Related Services

Audits related Services

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As a Third Party CGMP audits. We perform GMP audits of

APIs Manufacturer
Key Starting Material suppliers
Contract Manufacturers and intermediates
Excipients (incl. basic chemicals, cosmetic ingredients, disposables, etc).
GMP of finished dosage forms (solid, semi-solid, liquid, sterile, etc.)
GMP of packaging materials
Good Document Practices Audits
Due-diligence Technically evaluating Pharmaceutical Plants for acquisition
Clinical Laboratories Audits by qualified associates.
Pharma warehouses and storage facilities

Best Reason For Choose Our Consultancy Service

Audit word is derived from the Latin word “audire”. means “to hear”, “to listen” and In General “Auditing” is an attempt to ensure that the systems are properly maintained and not fault-finding exercise.

Sourcing of starting materials and active pharmaceutical ingredients (API) from third countries is common practice, the main supplier countries being China and India.

GMP certificates from third countries are not considered sufficient to ensure compliance with GMP Guidelines. Only API audits of the specific active pharmaceutical ingredients, performed on site, are accepted by the regulatory authorities and Third-party audits by contract partners are obviously permitted.

We provide comprehensive audit report which gives somewhat trailer of the GMP status of audited facility, Its GMP system and practices followed. Such audits

Enhance the confidence
Eliminate Any Risk of regulatory consequence, Product adulteration or risk on patient.
Creates Win Win situation at supplier and customer end
Business Continuity at both ends.
Continuously improve your processes

Trustworthy Customer Relationship

Full control of the audit report with technical and confidentiality agreements with no further distribution of the report except permitted by client.
Standardised, transparent audit procedure
Full confidentiality and an audit by an independent, professionals
Experienced, qualified auditors with a correct understanding of globally accepted standards

We provide specific support for important audits, like:

For-cause-audits
For FDA-readiness audits
For GAP analysis audits
GMP audits focussing on specific areas
Highly sophisticated process/product audits
Outstanding or challenging tasks.
Due Diligence for Pharmaceutical plants acquisition

We provide services for technically evaluating Pharmaceutical Plants for acquisition. Due-diligence is conducted with current systems and facilities and provides consolidated report regarding facilities and GMP competency of the unit.

Audited API facilities in last 2 years

Alchem	Cipla	Emcure	Hetero	Laurus	Neuland	Sun	Vamsi
Apicore	Curia	Emmanure	Honour	Medigraph	Polipeptide	Suvan	Wockhardt
Aurore	Chromo	Dr. Reddy’s	Intas	MSN	R A Chem	Shilpa
Aragen	Divis	Exemed	Harman	Mylan		Sairam
Amoli	Centrient		JPR			Sashi