Gujarat Technological University 2010 M.Pharm Good Manufacturing And Good Laboratory Practice - Question Paper

Q.1 (a) What is GLP? define the responsibilities of the Quality assurance unit of
a non-clinical testing laboratory.
06
(b) elaborate the important factors considered while selecting and purchasing an
equipment for manufacturing?
05
(c) elaborate the guidelines provided regarding use of automatic, mechanical and
electronic equipment.
05
Q.2 (a) explain the GMP guidelines for testing and approval / rejection of
components, drug product containers and closures.
06
(b) Write a note on Vendor Certification. 05
(c) What is a pharmaceutical warehouse? explain briefly the good warehousing
procedures.
05
Q.3 (a) Enlist the different records needed to be maintained in pharmaceutical
manufacturing , control and distribution of drug products.
06
(b) define the key components of a master manufacturing record. 05
(c) discuss the significance and the GMP regulations regarding expiration
dating of drug products.
05
Q.4 (a) define the in-process quality checks performed on different dosage forms. 06
(b) define briefly a good sampling procedure for sampling of starting
materials.
05
(c) elaborate reserve samples? explain briefly their significance. 05
Q.5 (a) explain the guidelines provided for issuing of printed tags to prevent possible
labeling errors and mix-ups.
06
(b) Enumerate the tests carried out on plastic packaging materials. 05
(c) discuss briefly the important elements of the WHO Certification scheme. 05
Q. six (a) What is product recall? Classify their kinds and discuss the procedures to be
followed for recalling a product.
06
(b) elaborate standard operating procedures? elaborate the factors that must be
considered while writing a SOP?
05
(c) elaborate Quality audits? Classify their different kinds. define the purpose
of carrying out Internal audits.
05
Q.7 (a) explain the general guidelines provided for Personnel selection and training. 06
(b) define the general guidelines to be followed for design and use of
documents. What minimum info must a finished product tag bear?
05
(c) What is pharmaceutical waste? define the waste disposal procedures and
the records to be kept for them.
05

Earning:   Approval pending.