introduction

Question 1

what is a formula

Answer 1

listing ingredients and their
percentages

Question 2

what is a procedure

Answer 2

to manufacture the formula

Question 3

what are equipments

Answer 3

Equipment to be used during manufacturing

Question 4

what is a personnel

Answer 4

people who run equipment and
follow the procedure.

Question 5

what is extemporaneous dispensing

Answer 5

is a small scale production of dosage forms prepared in community or hospital pharmacy.

Question 6

what is mass production

Answer 6

Mass production of pharmaceutical dosage forms is based on large (commercial) scale performed in industrial pharmaceutical companies.

Question 7

what are the challenges of mass production

Answer 7

1. Production requires large-scale equipment.
2. Production requires personnel with good knowledge of operation, maintenance, and calibration of the equipment.
3. The dosage form must have long-term stability, because it
   may remain for long time on shelf and not prepared for the patients on order (as in extemporaneous compounding).
4. Mass production is for many patients, which means that an
   error would have a devastating effect on public health.
   Accordingly, the manufacturing process must be performed
   under strict quality control system that ensures that the manufacturing process leads to safe, effective and stable dosage forms.

Question 8

what are the steps of product development

Answer 8

1.Preformulation.
2.Optimization.
3.Scale up.
4.Process validation.

Question 9

what is the definition and objective of preformulation?

Answer 9

Preformulation is an investigation of physical and chemical properties of drug substance alone and when combined with excipients.

The objective of preformulation is:
to generate information useful in the development of a dosage form that is stable, bioavailable and can be mass produced.

Question 10

what is optimization and what is it required for

Answer 10

the precise determination of the best formula, manufacturing process parameter and analytical methods.

optimization is required for:

Formula (e.g. excipient levels)

Process (i.e. manufacturing process parameters)

Analytical method to test the formula

Question 11

what is scaling up? and does it cause more problems?

Answer 11

gradual increase of the size of the batch of a pharmaceutical dosage forms.

yes the bigger the more

Question 12

what are the 3 stages of scaling up?

Answer 12

 Laboratory batch (1X – e.g. 3-5 kg of solid or semisolid, 3-5 L of liquids)

 Laboratory pilot batch (e.g. 10X - 30-50 kg for solids and semisolids, 30-50 L for liquids

 Pilot production (e.g. 100 X - 300-500 kg for solids and semisolids, 300-500 L for liquids)

Question 13

what is process validation

Answer 13

The objective of PV is to check for the stability and reproducibility of a process.

Question 14

how is process validation done ?

Answer 14

 After a pilot production was reached and showed good characteristics during the scale up, validation is done by manufacturing several batches (minimum 3) at different times.

 The manufactured batches should show low variability with respect to certain parameters (such as in the case of tablets: disintegration, dissolution and tablet hardness).

Question 15

what are the different departments of a pharmaceutical company

Answer 15

Research and Development (R&D)
department.

Production department.

Quality Control department (QC).

Quality Assurance department
(QA).

Question 16

what are the R&D department sections?

Answer 16

1. Product development section.

 It is responsible for the preformulation, optimization, scale
up and stability studies.
 It usually has small scale laboratory and pilot plant for the scale up. The pilot plant uses the same equipment used for manufacturing in the production department but on a smaller scale.

2. Analytical method development section.

 It is responsible for the development of analytical testing
procedures (e.g. analytical method development fordrug assay).
 It carries out the work in analytical laboratories.

Question 17

what is the production department responsible for

Answer 17

running the manufacturing processes on a large scale according to the formulation and procedure developed by the R&D department.

It has manufacturing rooms for milling, mixing, granulation, tableting etc. with large scale
equipment to perform these tasks.

Question 18

what is the QC department responsible for?

Answer 18

sampling and testing the semi
finished and finished product.

It has analytical labs with instruments (e.g. UVs and HPLCs) to run various tests.

Test procedures developed by the R&D department (analytical method development section) are followed by the QC.

 Responsible for making sure that the Good Manufacturing Practices (GMPs) are actually being applied
.
 How does QA check that GMPs are followed?
By inspecting the practices followed during manufacturing.

Question 19

GMPs are guidelines that are translated into
procedures that will ensure the product’s quality during
its manufacturing.
GMPs cover all elements of manufacturing process:
personnel, raw material, equipment, documentation.

Question 19

GMPs are guidelines that are translated into
procedures that will ensure the product’s quality during
its manufacturing.
GMPs cover all elements of manufacturing process:
personnel, raw material, equipment, documentation.

Question 20

give examples on regulators in the pharmaceutical industry

Answer 20

UK MHRA

Europe EMEA

USA FDA

Japan PFSB

Australia TGA

International ICH

Question 21

What are the stages of the development process

Answer 21

• Discovery and Pre-phase I
• Early Phase I
• Phase I (FIM studies) and Early Phase II
• Late Phase II and Early Phase III
• Phase III and Marketing Application
• Post Marketing
• X Years Post Marketing

Question 22

what documents do you need to get a pharmaceutical manufacturer’s license

Answer 22

In addition to routine documentation associated with GMP, the
manufacturer also has to have in place three major documents : • Site Master File. • Quality Manual.
• Validation Master Plan

Question 23

what is the site master file

Answer 23

is the site’s top GMP document giving a general overview about the site and it’s operations. A SITE MASTER FILE
is prepared by the manufacturer containing specific and factual GMP information about the production and/or control of pharmaceutical
manufacturing operations carried out at the named site and any closely integrated operations
at adjacent and nearby buildings.

Question 23

what is the site master file

Answer 23

is the site’s top GMP document giving a general overview about the site and it’s operations. A SITE MASTER FILE
is prepared by the manufacturer containing specific and factual GMP information about the production and/or control of pharmaceutical
manufacturing operations carried out at the named site and any closely integrated operations
at adjacent and nearby buildings.

Question 24

what is the validation master plan

Answer 24

The Validation Master Plan (VMP) is one of the most important
documents because it describes the basic concept for the overall
site validation programme.

The VMP addresses process validation, facility qualification and
validation, utility qualification and validation, equipment qualification and cleaning validation.

Question 25

what is the quality manual?

Answer 25

A Quality Manual is a top-level document that describes and norganisation’s Quality Management System (QMS)

the Quality Policy (which provides direction and a vision for an
organisation), the scope of the QMS (what parts of the organisation does the QMS cover or not cover),
the pharmaceutical quality system processes (what are the key activities that occur at the organisation – such as purchasing, goods-in, manufacture, testing, etc.)

as well as management responsivities (who are Senior Management and what is their involvement with the QMS)