CleanTech Solution

Pharmaceuticals

WHO

Non Statutory in Nature
Non Statutory in nature
Statutory

USFDA & EMA

Statutoy

WHO

The WHO Expert Committee on Specifications for Pharmaceutical Preparations meets now annually and their reports (Technical Report Series) include all adopted guidelines in the form of Annexes.
TRS 1019
Annexure 2 : Guidelines on heating, ventilation and air-conditioning systems for non-sterile pharmaceutical products
Part 2: Interpretation of Guidelines on heating, ventilation and air-conditioning systems of TRS 1010 Annex 8 for non-sterile pharmaceutical products
Annexure 3: Good manufacturing practices: guidelines on validation
Annexure 4: Protocol to conduct equilibrium solubility experiments for the purpose of Biopharmaceutics Classification System-based classification of active pharmaceutical ingredients for biowaiver.

TRS 996
Annex 1 : Good pharmacopoeial practices
Annex 3 : WHO good manufacturing practices for biological products
Annex 5 : Guidance on good data and record management practices

TRS 992
Annex 4 : General guidance on hold-time studies

TRS 986
Annex 2 : WHO good manufacturing practices for pharmaceutical products: main principles

TRS 970
Annex 2 : WHO good manufacturing practices: water for pharmaceutical use

TRS 961
Annex 6 : WHO good manufacturing practices for sterile pharmaceutical products

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ICH

Safety Guidelines ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. A recent breakthrough has been a non-clinical testing strategy for assessing the QT interval prolongation liability: the single most important cause of drug withdrawals in recent years
Quality Guideline Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.
Efficacy Guidelines The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials. It also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics/genomics techniques to produce better targeted medicines.
Multidisciplinary Guidelines Those are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories. It includes the ICH medical terminology (MedDRA), the Common Technical Document (CTD) and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI)

CDSCO

The Central Drugs Standard Control Organisation (CDSCO) under Directorate General of Health Services,Ministry of Health & Family Welfare,Government of India is the National Regulatory Authority (NRA) of India.
The Drugs & Cosmetics Act,1940 and rules 1945 have entrusted various responsibilities to central & state regulators for regulation of drugs & cosmetics. It envisages uniform implementation of the provisions of the Act & Rules made there under for ensuring the safety, rights and well being of the patients by regulating the drugs and cosmetics. CDSCO is constantly thriving upon to bring out transparency, accountability and uniformity in its services in order to ensure safety, efficacy and quality of the medical product manufactured, imported and distributed in the country.
Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country and coordination of the activities of State Drug Control Organizations by providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.
Further CDSCO along with state regulators, is jointly responsible for grant of licenses of certain specialized categories of critical Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera.

Schedule M deals with Good manufacturing Practice .

Schedule L1 deals with Good Laboratory Practice

The whole Drugs and Cosmetics Act can be found here