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rx-360-logo.jpg  Rx-360 Flash Report #348
A Nonprofit Organization

Brazil’s ANVISA Published Requirement for GMP Compliance by Manufacturers of Pharmaceutical Excipients
On May 28, 2012, Brazil’s ANVISA published a draft Resolution that would require GMP compliance by manufacturers of pharmaceutical excipients.  The consultation period of 60 days began seven days after its publication.  Rx-360 received the following question from our members: 

Question: When these requirements were first published, Rx-360 received a variety of input as to whether this just applied to drug product manufactured in Brazil or did it apply to drug product IMPORTED into Brazil or some combination thereof? 

Answer: The ANVISA response to the Swiss authority, question and response attached here, clearly states that “at this time it applies only to Brazilian companies”.

Requirements for Drug Product Made in Brazil: The GMPs for excipients in this draft act include eight chapters generally reflective of the type of requirements that are applied to human medicinal products and their APIs.  If this Resolution is finalized as written it would require manufacturers of excipients to comply with the following general requirements:
  • General Considerations
    • Excipient manufacturers must hold a working authorization and sanitary license
    • Excipient manufacturers would be subject to inspection by the competent authorities
    • The manufacturer must state and justify at which point GMPs are applied based on the step(s) in the process where the quality of raw materials and intermediates can have “critical influence” on the quality of the excipient
  • Quality Management including specified responsibilities of the Quality unit and requirements for self inspection
  • Personnel: including general hygiene, health exams, GMP training, and prohibitions on the wearing of watches, jewelry and makeup in areas where product is exposed
  • Buildings and Facilities
  • Prohibition of the manufacture of highly toxic non-pharmaceutical ingredients in the same facilities or equipment as excipients
    • Cleaning and sanitization of equipment, cleaning of facilities and pest control expectations
    • Disposal of waste materials
  • Equipment
  • Documentation and Records
  • Materials Control including sampling, testing, reuse and rework, solvent recovery, and prohibition against blending to meet quality standards
  • Production including expectations regarding water quality
  • Packaging, Labeling and Dispatch including specific information that must be on the label
  • Quality Control for raw materials, in process streams, final excipient, retention samples, control of impurities and stability evaluation to support retest or expiry dating
  • Change Control
  • Complaints Recalls and Returns
  • The draft states that while the Resolution will take effect on the date of its publication, existing establishments will have 12 months to fully comply.  New facilities must fully comply immediately and are not provided with the 12 month grace period.
To view or download the ANVISA Draft Resolution, click here

To view or download the Rx-360 Summary of the Draft Resolution, click here

To view or download the question on applicability by the 
Swiss Authority,
 click here

To view or download the ANVISA response to the 
Swiss Authority,
 click here

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