Professional Documents
Culture Documents
ICH Guidelines
ICH Guidelines
Quality Guidelines
Analytical validation Q2
Pharmacopoeias Q4 - Q4B
Q4 Pharmacopoeias
Q4A Pharmacopoeial Harmonisation
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
Q4B Annex 1R1Residue on Ignition/Sulphated Ash General Chapter
Q4B Annex 2R1Test for Extractable Volume of Parenteral Preparations General Chapter
Q4B Annex 3R1Test for Particulate Contamination: Sub-Visible Particles General Chapter
Q4B Annex 4AR1Microbiological Examination of Non-Sterile Products: Microbial Enumeration
Tests General Chapter
Q4B Annex 4BR1Microbiological Examination of Non-Sterile Products: Tests for Specified
Micro-Organisms General Chapter
Q4B Annex 4CR1Microbiological Examination of Non-Sterile Products: Acceptance Criteria
for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter
Q4B Annex 5R1Disintegration Test General Chapter
Q4B Annex 6Uniformity of Dosage Units General Chapter
Q4B Annex 7R2Dissolution Test General Chapter
Q4B Annex 8R1Sterility Test General Chapter
Q4B Annex 9R1Tablet Friability General Chapter
Q4B Annex 10R1Polyacrylamide Gel Electrophoresis General Chapter
Q4B Annex 11Capillary Electrophoresis General Chapter
Q4B Annex 12Analytical Sieving General Chapter
Q4B Annex 13Bulk Density and Tapped Density of Powders General Chapter
Q4B Annex 14Bacterial Endotoxins Test General Chapter
Q4B FAQsFrequently Asked Questions
Pharmaceutical Development Q8
Safety Guidelines
Genotoxicity Studies S2
Toxicity Testing S4
Reproductive Toxicology S5
Biotechnological Products S6
Immunotoxicology Studies S8
Efficacy Guidelines
Dose-Response Studies E4
Ethnic Factors E5
Multidisciplinary Guidelines
MedDRA Terminology M1
Electronic Standards M2
Gene Therapy M6
Genotoxic Impurities M7
SOP
In clinical research, the International Conference on Harmonisation (ICH) defines SOPs as "detailed,
written instructions to achieve uniformity of the performance of a specific function". SOPs get usually
applied in pharmaceutical processing and for related clinical studies. There the focus is set on always
repeated applying of unchanged processes and procedures and its documenting, hence supporting the
segregation of origins, causes and effects. Further application is with triage, when limited resources get
used according to an assessment on ranking, urgence and staffing possibilities. [1] Study director is mainly
responsible for SOPs. The Quality Assurance Unit are individuals who are responsible for monitoring
whether the study report and tests are meeting the SOP.