Manufacture & Import Controls – GMP/GDP

Question 1

GMP guidelines for TPs to follow

Answer 1

PICS GMP guidelines

Question 2

GMP guidelines for CTGTP to follow

Answer 2

GMP standard for CTGTP on HSA website

Question 3

GMP guidelines for Medical devices to follow

Answer 3

ISO 13485 standard

Question 4

GDP guidelines for medical device to follow

Answer 4

“Guidance Notes on GDP” set out on HSA’s website.

Question 5

GDP guidelines for TPs/ CTGTPs to follow

Answer 5

either “ISO 13485” standard or “Good Distribution Practice for Medical Devices” is acceptable

Question 6

PICS GMP stand for

Answer 6

Pharmaceutical Inspection Co-operation Scheme Guide to Good Manufacturing Practice for Medicinal Products

Question 7

For TPs, how long should records of manufacture be retained for?

Answer 7

r31: For 1 year after expiry date of TP or 5 years after manufacturing date, whichever is longer

Question 8

For TPs, how long should records of supply be retained for?

Answer 8

r32: For at least 2 years from date of supply

Question 9

For CTGTP, how long should records related to traceability and supply be retained for?

Answer 9

r32:
For at least 30 years after expiry date or shorter period allowed by HSA

Question 10

For medical device, how long should records of manufacture & supply be retained for?

Answer 10

r38 & 39:
For projected useful life of medical device or 2 yrs after date of supply, whichever is longer