New edition of study guide essential for those aspiring to be Qualified
Persons
 A new edition of the “Study guide — guide to the knowledge and practical experience required by Qualified Persons in the pharmaceutical industry” by the joint professional bodies administering the QP scheme, the Royal Pharmaceutical Society, the Royal Society of Chemistry and the Institute of Biology, is now available.
The guide aims to help applicants applying for certification as a Qualified
Person by setting out the body of knowledge and practical experience
required when certifying medicinal products suitable for release within
the pharmaceutical industry. It has been compiled by an expert working
group and approved by the Medicines and Healthcare products Regulatory
Agency and the Veterinary Medicines Directorate.
The revised version takes into account changes in manufacturing legislation,
and includes minor changes to requirements and a revision of dosage form
requirements. It is used by the joint professional bodies to interpret
the requirements of the Pharmaceutical Directive 2001/83/EC and the Veterinary
Directive 2001/82/EC.
QP officer for the Royal Pharmaceutical Society, Sadia Khan, said: “This
is an essential study guide for any applicant wanting
certification for eligibility as a Qualified Person. It outlines the
comprehensive body of knowledge and understanding required to gain certification.”
The new edition has replaced the previous edition issued in 2000 and
is available on the Society’s website (www.rpsgb.org), along with
other essential documents for those applying for QP status. Pharmacists
or sponsors wanting to find out more about the revised study guide and/or
any aspects of the oral assessment process can contact Royal Pharmaceutical
Society assessors for an informal discussion via Sadia Khan (email sadia.khan@rpsgb.org or telephone 020 7572 2537).
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