Pharmaceutical

Pharmaceutical industry is a very highly regulated sector and the Regulatory and Thoyiban aspects of halal pharmaceuticals are very much integrated within the requirements of producing halal pharmaceutical products. The halalan or shariah requirements, nevertheless, is similar to any other industries, with ingredients and processing plays pivotal role in ensuring the integrity of halal products produced within the mandatory requirements for its safety and quality aspects. It is estimated that the global market for pharmaceutical industry in 2013 is USD818 billion and by year 2020 it is estimated to reach USD1,300 billion. The main challenges faced by the pharmaceutical industry in complying with halal certification requirements lies in the ingredients used. Proper strategies need to be in place as to avoid prolong process of ingredients screening and rejections due to unnecessary risks of cross-contamination.

Normative References:

  1. MS2424:2012 – Halal Pharmaceuticals – General Guidelines
  2. Malaysian Halal Certification Manual Procedure 2014 (3rd Revision)
  3. Pharmaceutical Inspection Cooperation Scheme (PIC/S): Guide to Good Manufacturing Practice for Medicinal Products
  4. Pharmaceutical Inspection Cooperation Scheme (PIC/S): Guide to Good Manufacturing Practice for Medicinal Products Annexes
  5. MS 2565:2014 - Halal packaging - General guidelines