ICH GUIDELINES for Quality

Q 1 A) Stability test for new drug and products

B) Photo Stability test for new drug and products

C) Bracketing and design for Stability test for new drug and products

D) Evaluation of Stability data

E) Stability data Package for new registration and application in Climatic

Zone III and IV

Q 2) Analytical method validation.

Q 3) Impurities in new drug substances.

Impurities in new drug products

Guidelines for Residual solvents

Q 4) Pharmacopieas

 Residue on ignition/Sulphated ash

 Test for Extractable volume from parental preparations
 Test for particulate contamination
 Disintegration test
 Uniformity of dosage unit
 Dissolution test
 Sterility test
 Tablet friability
 PAGE
 Capillary electrophoresis
 Analytical sieving
 Bulk density and tapped density
 Bacterial end toxin

4 A) Microbial enumeration
4 B) Test for specified micro organisms.
4 C) Accpetance.Criteria for Pharmaceutical preparations and substances for use.
Q5) A) Viral safety evaluation of biotech products derived from cell lines of
animal origin or Human.
B) Quality of biological products: Analysis of the expression construct in cells
used for Production Of R-DNA derived proteins.
C) Stability of Biotech/Biological products.
D) Derivation and characterization of cell substrate used for production
Of Biotech/Biological Products.
E) Comparability of Biotech/Biological Products Subject to changes in their
manufacturing Process.
Q6) A) Test procedure and acceptance criteria for new drugs substances and
new drugs: Chemical Substances.
B) Test procedure and acceptance criteria for new drugs substances and
new drugs: Biological Substances.
Q7)
1. Introduction
2. Quality Management
3. Personnel
4. Building facilities
5. Process equipments
6. Documentation and Records
7. Materials Management
8. Production and in –process controls
9. Packaging and identification labeling of API’S and INT’S
10. Storage and Distribution
11. Laboratory control
12. Validation
13. Change control
14. Rejection and re-use of materials
15. Complaints and Recalls
16. Contact manufacturing
17. Agents,Brokers,Traders,Distrubutors,Repacking and Relabellers
18. Specific Guidance for API’S Manufacturing by cell Culture/Fermentation
19. API’S for use in clinical trials.
20. Glossary
Q8) Pharmaceutical development
Q9) Quality risk management
Q10) Pharmaceutical Quality system
Q11) Development and manufacturing of Drug substances (Chemical /Biological entities)
Q 12) Life cycle management
Q 13) Continuous manufacturing of drug substance and drug products
Q 14) Analytical procedure development.
 ICH GUIDELINES for efficacy

E 1: The extent of population exposure to assess clinical safety for drugs intended for long-
term Treatment of non-life-threatening conditions.
E 2A: Clinical safety data management: definitions and standards for expedited reporting.
E 2B: Maintenance of the ICH guideline on clinical safety data management: Data elements
for transmission of individual case safety reports.
E 2C: Periodic Benefit-Risk Evaluation Report (PBRER)
E 2D: post-approval safety data management: definitions and standards for expedited
reporting.
E 2F: Development Safety Update Report.
E 4: Dose-Response Information to Support Drug Registration.
E 5: Ethnic Factors In The Acceptability Of Foreign Clinical Data.
E 6: Guideline for Good Clinical Practice.
E 7: Studies In Support Of Special Populations: Geriatrics (The branch of medical science
that deals with diseases and problems specific to old people).
E 8: General Considerations for Clinical Trials.
E 9: Statistical Principles for Clinical Trials.
E10: Choice of control group and related issues in clinical trials.
E 11: Clinical Investigation Of Medicinal Products In The Pediatric Population.
E 12: Principles for Clinical Evaluation Of New Antihypertensive Drugs.
E 14: The Clinical Evaluation Of Qt/Qtc Interval Prolongation and Pro arrhythmic Potential
Non-Antiarrhythmic Drugs.
E16: Biomarkers Related To Drug Or Biotechnology Product Development: Context,
Structure and Format Of Qualification Submissions.
 ICH GUIDELINES for Safety

S 2: Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended For
Human Use.

S 3 A: Note for guidance on toxicokinetics: The assessment of systemic exposure in toxicity studies.

S 3 B: Pharmacokinetics: Guidance For Repeated Dose Tissue Distribution Studies .

S 4: Duration of Chronic Toxicity Testing In Animals (Rodent and Non Rodent Toxicity Testing).

S 5: Detection of Toxicity to Reproduction For Medicinal Products & Toxicity To Male Fertility.

S 6: Preclinical safety evaluation of Biotechnology-derived pharmaceuticals.

S 7: Safety Pharmacology Studies for Human Pharmaceuticals.

S 8: Immunotoxicity Studies for Human Pharmaceuticals.

S 9: Nonclinical Evaluation for anticancer Pharmaceuticals

ICH GUIDELINES for Multidisplinary

M 1: Med DRA Terminology: M2: Electronic Standards.

M3: Non clinical Safety Studies.
M4: Common Technical Document.
M5: Data Elements & standards for Drug dictionaries.
M6: Gene Therapy.
M7: Genotoxic Impurities (Assessment and Control of Dna Reactive (Mutagenic) Impurities in
Pharmaceuticals to Limit Potential Carcinogenic Risk)
M8: Electronic common Technical Document.
M9: Biopharmaceuticals classification system-based Biowaivers.
M10: Bio analytical method validation.
 Name of Contact Designation Email address Cell Number
Y.Aravinda Srinivasu Plant Head svllvizag@gmail.com +91-7893601278
V.Basava Raju Accounts Head srivyjayanthilabspvtltd@gmail.com +91-9573711278
M. Satya sowmya Technical Head smudunuri.svll@gmail.com +91-9618943559
V.Madhava Rao Quality Assurance svllqa@gmail.com +91-9963471278
Manager