Analytical Testing for the Pharmaceutical GMP Laboratory
Kim Huynh-Ba
- Provides
- practical
- guidance
- on
- pharmaceutical
- analysis,
- written
- by
- leading
- experts
- with
- extensive
- industry
- experienceAnalytical
- Testing
- for
- the
- Pharmaceutical
- GMP
- Laboratory
- presents
- a
- thorough
- overview
- of
- the
- pharmaceutical
- regulations,
- working
- processes,
- and
- drug
- development
- best
- practices
- used
- to
- maintain
- the
- quality
- and
- integrity
- of
- medicines.
- With
- a
- focus
- on
- smaller
- molecular
- weight
- drug
- substances
- and
- products,
- the
- book
- provides
- the
- knowledge
- necessary
- for
- establishing
- the
- pharmaceutical
- laboratory
- to
- support
- Quality
- Systems
- while
- maintaining
- compliance
- with
- Good
- Manufacturing
- Practices
- (GMP)
- regulations.Concise
- yet
- comprehensive
- chapters
- contain
- up-to-date
- coverage
- of
- drug
- regulations,
- pharmaceutical
- analysis
- methodologies,
- control
- strategies,
- testing
- development
- and
- validation,
- method
- transfer,
- electronic
- data
- documentation,
- and
- more.
- Each
- chapter
- includes
- a
- table
- of
- contents,
- definitions
- of
- acronyms,
- a
- reference
- list,
- and
- ample
- tables
- and
- figures.
- Addressing
- the
- principal
- activities
- and
- regulatory
- challenges
- of
- analytical
- testing
- in
- the
- development
- and
- manufacturing
- of
- pharmaceutical
- drug
- products,
- this
- authoritative
- resource:Analytical
- Testing
- for
- the
- Pharmaceutical
- GMP
- Laboratory
- is
- a
- must-have
- reference
- for
- both
- early-career
- and
- experienced
- pharmaceutical
- scientists,
- analytical
- chemists,
- pharmacists,
- and
- quality
- control
- professionals.
- It
- is
- also
- both
- a
- resource
- for
- GMP
- laboratory
- training
- programs
- and
- an
- excellent
- textbook
- for
- undergraduate
- and
- graduate
- courses
- of
- analytical
- chemistry
- in
- pharmaceutical
- sciences
- or
- regulatory
- compliance programs.
