| Few would argue with the need for pharmaceutical businesses to follow safe and
proven quality assurance procedures. To this end, companies have been operating
traceability systems and keeping records founded on good manufacturing practice
(GMP) and good distribution practice (GDP) for a number of years. More recently,
as automated monitoring and recording systems have become more commonplace,
21 CFR Part 11 has been introduced and provides appropriate guidelines for
the application of electronic record keeping and signatures. Effectively, 21 CFR
Part 11 defines the criteria under which electronic records and electronic
signatures are considered to be trustworthy and reliable. MHRA guidelines
share many of the safeguards.
Temperature and humidity have
always been important factors in the
pharmaceutical industry, but never more
so than now. Levels in key areas, such
as laboratories, cold stores, chill rooms,
incubators, test chambers, production
processes and storage areas need to be
regularly monitored and procedures put in
place to establish corrective actions if they
move outside pre-set limits. Documents,
together with complete and comprehensive
records, need to be kept and electronic
systems need to comply with necessary
guidelines. |
