Drug market approval tests: The qualitative basis of the approval process
The development of a drug includes years of research and development work as well as preclinical and clinical studies. But even when all this work is completed, the last and decisive phase follows before the drug can be brought onto the market: the . In this process, the quality, safety and efficacy data submitted to the regulatory authorities must be fully verifiable and in line with international standards.
Drug market launch tests form the basis of the quality section of this document. These tests, which are required by the Tİtck (Turkish Drug and Medical Devices Authority) in Turkey by the EMA (European Medicines Agency) in Turkey, and the FDA (Food and Drug Administration) in the USA, prove the identity, purity, Efficacy, stability and biological effectiveness of the drug. The performance of the tests in accordance with the principles of GLP (Good Laboratory Practice) and the GMP (good manufacturing practice) is mandatory for the acceptance of the application for admission.
The Joint Technical Dossier (CTD) in the approval process
Drug approval applications are prepared in the CTD format (Common Technical Document) as part of international harmonization. The CTD consists of five modules, with the quality data included in Module 3 (Quality). The market approval tests directly form the content of this module:
- Module 1: Administrative Information and Regional Requirements
- Module 2: Quality, Safety and Efficacy Summaries (QoS, Noclinical, Clinical)
- Module 3: Quality (chemical, pharmaceutical and biological data)
- Module 4: Reports on Preclinical Studies
- Module 5: Clinical Studies Reports
The test data presented under Module 3 are prepared separately for the pharmaceutical active ingredient (API) and the finished medicinal product. These data must comply with the ICH guidelines (Q1-Q14).
Main categories of market approval tests
The tests required for the approval of a medicinal product can be divided into the following main categories:
1. Identity and Purity Checks
They prove that the drug is the active ingredient indicated and that it has an acceptable degree of purity. They are carried out according to the ICH guidelines Q3A, Q3B, Q3C and Q3D.
- Identity (Identity): Confirmation of the active ingredient (API) using FTIR, HPLC and NMR
- Contaminant Profile: Organic Impurities, Solvent Residues, Heavy Metals
- Anantiomer purity: Ratio of optical isomers using chiral HPLC
2. Salary determination and salary uniformity
Verification of the active substance content of the product and the consistency between the individual doses.
- Assay (salary determination): Determination of API content using HPLC
- Content uniformity: according to the requirements of the pharmacopoeia
- Resolution Speed (Dissolution): for solid oral dosage forms
3. Stability Tests (I Q1)
Proof that the product maintains its quality over the entire shelf life.
- Long-term stability: 25°C/60% r. F. or 30°C/65% R. f.
- Accelerated stability: 40°C/75% r. f.
- Intermediate stability: 30°C/65% r. f.
- Light Stability: I Q1B compliant light exposure
4. Bioavailability and Bioequivalence (I M13A)
Detects the equivalence of generics to the reference preparation.
- Verification of bioanalytical methods: Plasma analysis using LC-MS/MS
- Pharmacokinetic parameters: Cmax, AUC, Tmax
- Statistical Equivalence: 80-125% criterion at a 90% confidence interval
5. Microbiological Quality Tests
Are carried out for sterile products and products for which microbiological limit values are prescribed.
- Sterility test: Pharmacopee compliant
- Microbiological Limits: TAMC, TYMC and Detection of Pathogens
- Endotoxin test: LAL method
Summary of tests for market launch and related guidelines
The following table summarizes the basic tests required by the drug approval process and the associated ICH guidelines:
| Test category | Related ego guideline | Evaluated Parameter | CTD module |
|---|---|---|---|
| Identity and purity | I Q2A, Q3B, Q3C, Q3D, Q6A | Identity of the active ingredient, contamination profile, heavy metals | Module 3.2.s |
| Quantitative Determination | I Q2(R2), Q6A | API salary, uniformity of salary, solubility | Module 3.2.p |
| Stability | I Q1A(R2), Q1B, Q1E | Durability, degradation profile, light stability | Module 3.2.S.7 / 3.2.P.8 |
| Bioequivalence | I M13A, E6(R2) | Cmax, AUC, Tmax, statistical equivalence | Module 5.3.1 |
| Microbiological quality | I Q6A, Q4B | Sterility, Microbiological Limits, Endotoxins | Module 3.2.p.3 |
| Analytical Validation | I Q2(R2), Q14 | Accuracy, Accuracy, Specificity, Lod/Loq | Module 3.2.S.4 / 3.2.P.5 |
The role of GLP and GMP in the approval process
The validity of market approval tests depends not only on the use of correct analytical methods, but also on the fact that these tests are carried out in accredited laboratories and according to the GLP principles. GLP sets strict rules in areas such as personnel training, device calibration, standard work instructions (SOP), data integrity, and audit trail (Audit Trail).
Likewise, the GMP conformity of the manufacturing process is an inseparable part of the application for approval. The simultaneous compliance with GLP and GMP proves that the drug has a consistent quality, both in the laboratory and on the production scale.
GLP-compliant solutions for market approval tests with nano-test
The approval process for drug manufacturers requires intensive data preparation and careful analytical work. Nano-Test is a GLP-accredited solution partner who offers all the quality tests required in this process from a single source.
Nano-Test – Performance Description
NANO-TEST performs all quality inspections required for the market launch of pharmaceuticals in its GLP and ISO/IEC 17025-accredited laboratories. Our service portfolio:
- Identity and Purity Checks: API verification and creation of contaminant profiles using FTIR, HPLC-DAD, LC-MS/MS, GC-MS/MS and ICP-MS.
- Quantitative determination and uniformity of salary: Assay, salary uniformity and dissolution tests according to the monographs of the pharmacopoeias.
- Stability tests: long-term, accelerated and intermediate stability studies according to ICH Q1A(R2); Photostability checks according to ICH Q1B.
- Bioanalysis and bioequivalence: Analysis of plasma samples using LC-MS/MS, calculation of pharmacokinetic parameters and statistical evaluation of bioequivalence.
- Microbiological Quality: Sterility Tests, Tests to Determine Microbial Limits, Endotoxin Tests (LAL) and Preservative Efficacy Tests.
- Analytical validation: Method development, validation and transfer according to ICH Q2(R2) and Q14.
All of our work is presented in the form of reports in CTD format. The data integrity (ALCOA+ principles) is guaranteed and is justifiable for inspections by the approval authorities. GLP compliance reports are created.
Advantages of nano-test in market launch tests:
- One-stop solution: All identity, purity, stability, bioanalytical and microbiological tests under one roof.
- CTD-compliant reporting: Reports meeting the requirements of Module 3 and Module 5 and accepted by the regulatory authorities.
- Pursuing current legislation: Immediate adaptation to newly published guidelines such as me Q14.
- State-of-the-art technological infrastructure: LC-MS/MS, GC-MS/MS, ICP-MS, HPLC-DAD, and climate chambers.
- Specialist staff: A team with experience in the fields of pharmaceutical analysis, bioanalysis, validation and approval.
- Fast reporting: Delivery of results within 5–10 working days for standard analyses.
The market launch of drugs requires the successful completion of a comprehensive and careful test procedure. Identity, purity, salary, stability, bioequivalence and microbiological quality checks provide scientific evidence of the safety, efficacy and quality of the drug. The performance of these tests in accredited laboratories in accordance with the GLP principles and the complete reporting in CTD format are a prerequisite for accepting your application for approval.
With its GLP-accredited infrastructure, advanced analytical technologies and its professionals, Nano-Test fully meets the requirements of drug manufacturers for market approval tests. Collaborate with Nano-Test to speed up your application for admission and meet the requirements of the regulatory authorities.