Professional Documents
Culture Documents
International Pharmacopoeia
Most important factors that determine the safety and efficacy
- Standard of raw materials used in the manufacturing process
- Standard (specification) to which the final product is produced
Standard processes and guides to good manufacturing practice for
medicinal products : Play a central role in establishing criteria which
guarantee the consistent production of safe and effective bio-drugs
International Pharmacopoeias
- US (USP), European Pharma ( Eur. Ph.), Japanese Pharmacopoeia
Martindale
The extra pharmacopoeia
To provide concise, unbiased information regarding biodrugs of clinical interest, largely summarized from the
peer-reviewed literatures : not a book of standards
First edition published by William Martindale in 1883
- The 30th edition in 1993
Contains information on around 5,000 bio-drugs in
clinical use: Chemical-based drugs and traditional
biological substances like antibiotics, hormones, and
blood products
Manufacturing facility
Appropriate design and layout of the facility : Crucial to the
production of safe and effective medicines
Commonly contains :
- Specific production of a target drug
- Quality control, Storage areas, etc
cf) Injectable bio-drugs : Require unique facility design and
operation safety of product
- Clean room technology
- Generation of ultra pure water (WFI : water for injection)
- Proper design and maintenance of non-critical
areas : storage, labeling, and packing areas
Clean rooms
Environmentally controlled areas for injectable/sterile
biopharmaceutricals : specifically designed to protect the
product from contamination (microorganisms and particulate
matters etc.)
Designed in a way that allows tight control of entry of all
substances and personnel (e.g., equipment, in-process
product, air etc..)
A basic feature of design : Installation of high efficiency
particulate air (HEPA) filters in the ceilings :
Europe :
Grade A :
B:
C:
D:
5 m particle dia
0
0
2,000
20,000
USA :
class 100 (grade A/B),
class 10,000(grade C),
class 100,000 (grade D)
viable microorganisms
<1
5
100
500
Documentation
Adequate documentation : Essential part of GMP
Essential in order to
- Help prevent errors/misunderstandings associated
with verbal communication
- Facilitate the tracing of the manufacturing history of
any batch of product
- Ensure reproducibility in all aspects of pharmaceutical
manufacture
Categories
Most documents associated with biopharmaceutical
manufacturing fall into one of four categories
- Standard operating procedures (SOPs)
- Specifications
- Manufacturing formulae, processing and
packaging instructions
- Records
Documents should be written/worded in a clear and
unambiguous fashion by supervisory personnel and
inspected by senior technical personnel like production or
QC manager before final approval for general use
Specifications
Exact qualitative and quantitative requirements for raw
materials or product
- Specifications for raw material (ex., percentage active
ingredients, permitted levels of impurities)
- Specifications for packing materials (ex., exact dimension
of product packaging, details of product labels etc.)
- Specifications for final product (ex., purity, color,
formulation etc.)
Normally written by QC personnel
Specifications for raw materials / final product : conforming
with appropriate pharmacopoeia
Records
Maintenance of adequate and accurate records
For any given batch of product, records relating to every
aspect of manufacture are retained for at least 1 year
Records include:
- Specification results obtained on all raw materials
- Batch manufacturing, processing, and packaging records
- QC analysis results of bulk and finished product
The records should allow tracing back of all manufacturing
steps, for the case of any difficulty or problem regarding the
production of final product