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PIC/S SEMINAR – SINGAPORE (20-22 November)

A Seminar on the “Inspection of Manufacturers of Solid Dosage Forms” was held in Singapore from 20 to 22 November 2007. It was the first time that a PIC/S Seminar was held in Asia.

The PIC/S Seminar was organised by Singapore’s Health Science Authority (HSA). It was attended by almost 130 participants from 45 agencies from all continents (among which 13 from Asia). The number of participants and the number of agencies represented both constitute a record in PIC/S Seminar history. Inspectors from a number of non-Member agencies coming from Brunei Darussalam, China, Cyprus, the European Medicines Agency (EMEA), Georgia, Hong-Kong SAR1, Indonesia, Israel, Japan, Macau SAR1, NIS2, South Korea, New Zealand, Philippines, Taipei, Thailand, USA, Vietnam and WHO also participated in the seminar.

PIC/S Seminar was attended for the first time by representatives from Brunei Darussalam, Georgia, Hong-Kong SAR, Macau SAR, the Philippines, South Korea and Vietnam.

Among the seminar participants were also a number of speakers, session chairpersons and

workshop leaders. Speakers academia and industry.

were

mainly

provided

by

PIC/S

Participating

Authorities,

The Seminar focused on the following topics in the field of GMP inspection of manufacturers of solid dosage forms:

(i)

challenges and issues (e.g. the interface between GMP inspection and drug evaluation);

(ii)

technological advances and new initiatives (e.g. Process Analytical Technology and process understanding);

(iii)

production and quality control (e.g. control of starting materials, in-process & packaging controls, cleaning validation for multi-product manufacturing

(iv)

facilities); environmental control and segregation requirements (e.g

. air cleanliness

classification for manufacturing facilities).

An entire day was dedicated to parallel workshops. One workshop consisted in case studies on deficiencies and their classification during GMP inspection of solid dosage form manufacturers. Two other workshops were dedicated to the inspection of solid dosage form manufacturing facilities (air cleanliness, microbial & environmental monitoring) and to the need for dedicated equipment or segregated facilities for highly active and/or sensitising agents.

The presentations made at the Seminar will be made available on a CD-ROM (contact the PIC/S Secretariat (info@picscheme.org)).

******

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Special Administrative Region

New Independent States’ Interstate Commission on Standardisation, Registration and Quality Control of Medicines and Medical Devices

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