Out of all these guidelines, the one most relevant to us is the Quality guidelines. The areas covered under this are labeled from Q1 to Q11 and deal with different aspects of Quality Assurance (QA) relating to pharmaceuticals. Stability testing, analytical validation, impurities, quality systems, risk management, and GMP are some of the most important areas covered.
|
Guideline |
Subpart |
Area Covered |
|
Q1 Stability |
Q1 A |
Stability
testing of new drug substances and products. |
|
|
Q1 B |
Photostability
testing of new drug substances and products. |
|
|
Q1 C |
Stability
testing for new dosage forms. |
|
|
Q1 D |
Bracketing
and matrixing designs for stability testing of new drug substances and
products. |
|
|
Q1 E |
Evaluation of
stability data. |
|
|
Q1 F |
Stability
data package for registration applications in climatic zones III and IV. |
|
Q2 |
|
Validation of
analytical procedures. |
|
Q3 Impurities |
Q3 A |
Impurities in
new drug substances. |
|
|
Q3 B |
Impurities in
new drug products. |
|
|
Q3 C |
Guidelines
for residual solvents. |
|
|
Q3 D |
Guidelines
for elemental impurities. |
|
Q4
Pharmacopoeias |
Q4 A |
Pharmacopoeial
harmonization. |
|
|
Q4 B |
Evaluation
and recommendation of pharmacopoeial texts for use in ICH regions. |
|
Q5 Quality of
biotechnological products |
Q5 A |
Viral safety
evaluation of biotechnology products derived from cell lines of human or
animal origin. |
|
|
Q5 B |
Analysis of
expression constructs in cells used for the production of r-DNA derived
protein products. |
|
|
Q5 C |
Stability
testing of biotechnological/biological products. |
|
|
Q5 D |
Derivation
and characterization of cell substrates used for the production of
biotechnological/biological products. |
|
|
Q5 E |
Comparability
of biotechnological/biological products subject to changes in their
manufacturing process. |
|
Q6
Specifications |
Q6 A |
Test
procedures and acceptance criteria for new drug substances and new drug
products: Chemical substances. |
|
|
Q6 B |
Test
procedures and acceptance criteria for biotechnological/ biological products. |
|
Q7 |
|
Good
manufacturing practices for pharmaceutical ingredients. |
|
Q8 |
|
Pharmaceutical
development. |
|
Q9 |
|
Quality risk
management. |
|
Q10 |
|
Pharmaceutical
quality system. |
|
Q11 |
|
Development
and manufacture of drug substances (chemical and biological entities). |