BASAI STATEMENT

ON

BIOCHEMICAL EQUIVALENCE UNDER
GOOD LABORATORY PRACTICE

PROCEEDURE OF ESTABLISHING BIOCHEMICAL EQUIVALENCE AS PER FAO UNDER GLP SCHEME

AND
ADHERENCE TO MUTUAL ACCEPTANCE OF DATA ( MAD )

 

The joint FAO/WHO recommends a scientific procedure for the establishment of equivalence between active ingredients coming from different sources ( different source from in different countries, or different manufacturing sites within a country ).

A Material Accountability Report ( MRN ) is generated containing identification of all impurities present at concentrations greater than 0.1 mg/kg and identification and quantification of any relevant impurities, supported by analytical data for at least five typical batches analyzed under GLP norms as stated below:

  • Establishing minimum purity of active ingredient
  • Establishes maximum level for relevant impurities (whether less than or greater than 0.1%)
  • Establishes maximum level for non-relevant impurities only those > 0.1% (1g/kg) are listed
  • Additionally, details on manufacturing process is sought

Product is considered chemically equivalent if:

  • NO reduction in minimum purity of active ingredient
  • NO new relevant impurities
  • NO increase in existing relevant impurities
  • NO increase in non-relevant impurities unless meets equivalency test
    – an increase of 50% or 3g/kg (whichever is greater compared to Registered Specification) in non-
    relevant impurities is considered equivalent)
  • Decrease in impurity levels (higher purity of the active ingredient) is considered not of concern
  • Where there is NO Change in Registered Specifications, no additional studies, except for a required
    Ames Test. In case of any new identified impurity of toxicological significance being detected during the
    five batch analysis procedure, some additional toxicological tests may be required.
  • Where there is a change in the Registered Specification and equivalence cannot be demonstrated – additional testing is necessary as per Tier Approach of toxicological data requirement as recommended
    by FAO/WHO in line with OECD principles of the 3 R principle minimizing animals kill.

Further, five batch samples from small lab scale production or pilot scale production can be accepted for generating 5 batch impurity profiling Material Accountability Report.

The above process of chemical equivalence necessarily/mandatorily as per GLP analysis, is believed to be followed in most of the countries globally while India remains yet an exception. BIOLOGICAL AGRI SOLUTIONS ASSOCIATION OF INDIA fully supports this internationally accepted norm of FAO scheme of chemical equivalence. Acceptance of chemical equivalence analysis under GLP norms will also demonstrate India’s adherence to the Mutual Acceptance Data ( MAD ) principles of OECD of which India is signatory.

 

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We invite companies who operate in Biostimulants & Biological products for Agriculture sector. (No pharmaceutical, vet or any allied sectors) to join hands with us to take this initiative forward and jointly raise voice against common issues faced for the segment.

We invite companies who operate in Biostimulants & Biological products for Agriculture sector. (No pharmaceutical, vet or any allied sectors) to join hands with us to take this initiative forward and jointly raise voice against common issues faced for the segment.

AT A GLANCE

Front Brakes Repair $49.95
Rear Brakes Repair $59.95
Rear Brake Shoes $62.95
Axle $149.95 Each
Starters / Alternators $225.95 Plus Parts

SCOPE OF WORK

We offer full range of garage services to vehicle owners in Tucson. Our professionals know how to handle a wide range of car services. We can handle any problem on both foreign and domestic vehicles.

  • We make auto repair and maintenance more convenient for you
  • We are a friendly, helpful and professional group of people
  • Our professionals know how to handle a wide range of car services
  • We get the job done right — the first time
  • Same day service for most repairs and maintenance

We offer full range of garage services to vehicle owners in Tucson. Our professionals know how to handle a wide range of car services. We can handle any problem on both foreign and domestic vehicles.

  • We make auto repair and maintenance more convenient for you
  • We are a friendly, helpful and professional group of people
  • Our professionals know how to handle a wide range of car services
  • We get the job done right — the first time
  • Same day service for most repairs and maintenance
BASAI

Organic farming is beneficial to a wide range of organisms. It restores the biodiversity of the core resources and habitat of the region. The symbiosis between flora and fauna, animals, and humans with a chemical-free environment is paradise on Earth.

Contact

Anthony Benoit 490 E Main Street Norwich CT 06360
Phone: +1 (2) 345 6789
Fax: +1 (2) 345 6789

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