Knowledge Sharing

International trade fair for Laboratory Technology, Analysis, Biotechnology and Diagnostics |Hyderabad | 10 – 12 September 2026 | HITEX Exhibition Centre

CPHI & PMEC Shenzhen | 16 to 18 Sep 2026 | SZCEC | China

CPHI Milan 2026 | 6 to 8 Oct 2026 | Fiera Milano | Italy

AgroChemEx (ACE)|Shanghai |14 – 16 October 2026 |SWEECC

Pharmapack Asia | 3 to 4 Nov 2026 | Marina Bay Sands | Singapore

CPHI & PMEC India 2026 | Greater Noida |24 – 26 Nov 2026 |India Expo Centre

China International Agrochemical & Crop Protection |Exhibition |March 24-26, 2027 National Exhibition and Convention Center (Shanghai)

PharmaTech Expo | Chandigarh | 8 – 10 April 2027 | Parade Ground, Sector 17

CPHI Japan | 21 to 23 Apr 2027 | East Halls, Tokyo Big Sight | Tokyo, Japan

CPHI Americas | 25 to 26 May 2027 | Miami Beach Convention Center, Florida | USA

CPHI & PMEC China | 16 to 18 Jun 2027 | National Exhibition and Convention Center | Shanghai

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List of GLP Documents

No 1: OECD Principles on Good Laboratory Practice 

No 5: Compliance of Laboratory Suppliers with GLP Principles (revised in 1999)

No 6: The Application of the GLP Principles to Field Studies (revised in 1999)

No 7: The Application of the GLP Principles to Short Term Studies (revised in 1999)

No 8: The Role and Responsibilities of the Study Director in GLP Studies (revised in 1999)

No 11: The Role and Responsibility of the Sponsor in the Application of the Principles of GLP (1998)

No 12: Requesting and Carrying Out Inspections and Study Audits in Another Country (2002) –

No 13: The Application of the OECD Principles of GLP to the Organisation and Management of Multi-Site Studies 

No 14: The Application of the Principles of GLP to in vitro Studies (2004)

No 15: Establishment and Control of Archives that Operate in Compliance with the Principles of GLP (2007)

No 16: Guidance on the GLP Requirements for Peer Review of Histopathology (2014)

No 17: Application of GLP Principles to Computerised Systems (2016) – [replaces No. 10]

No 17 Supplement 1: Advisory Document on GLP & Cloud Computing (2023)

No. 19: Management, Characterisation and Use of Test Items (2018)

No. 22: GLP Data Integrity (2021)

No 23: Quality Assurance and GLP (Note: replaces  No. 4]

List of Position Papers

No. 18: OECD Position Paper Regarding the Relationship between the OECD Principles of GLP and ISO/IEC 17025 (2016)

No. 21: OECD Position Paper Regarding Possible Influence of Sponsors on Conclusions of GLP Studies (2020)

No. 24: Position Paper on Quality Improvement Tools and GLP (2022)

No. 25: OECD Position Paper on Good Laboratory Practice and IT Security (2024)OECD Test Guidelines

Q1A – Q1F Stability: Protocols for stability testing of new drug substances, products, and climatic zone variations.

Q2 Analytical Validation: Validation of analytical procedures and methodologies used in product testing.

Q3A – Q3E Impurities: Strict limits and guidelines for elemental, residual solvent, and mutagenic impurities.

Q4A – Q4B Pharmacopoeias: Harmonisation of international pharmacopoeial testing standards.

Q5A – Q5E Quality of Biotechnological Products: Safety testing of biological materials, viral safety, and cell substrates.

Q6A – Q6B Specifications: Setting test criteria and acceptance limits for chemical and biotechnological drug substances.

Q7 Good Manufacturing Practice (GMP): Comprehensive GMP requirements for active pharmaceutical ingredients (APIs).

Q8 Pharmaceutical Development: Quality by Design (QbD) principles applied to product development.

Q9 Quality Risk Management: Frameworks for identifying, assessing, and mitigating manufacturing and product risks.

Q10 Pharmaceutical Quality System: Modern model for a robust corporate pharmaceutical quality management system.

Q11 Development and Manufacture of Drug Substances: Guidance on selecting, developing, and manufacturing drug substances.

Q12 Lifecycle Management: Technical and regulatory tools for post-approval chemistry, manufacturing, and controls (CMC) changes.

Q13 Continuous Manufacturing: Regulatory expectations for moving from batch manufacturing to continuous processing.

Q14 Analytical Procedure Development: Minimal versus enhanced approaches to developing robust analytical testing methods

Fundamental State & Thermodynamic Properties

TG 101: UV-VIS Absorption Spectra

TG 102: Melting Point / Melting Range

TG 104: Vapour Pressure

TG 103: Boiling Point

TG 109: Density of Liquids and Solids

TG 113: Screening Test for Thermal Stability and Stability in Air

TG 114: Viscosity of Liquids

Solubility & Partition Coefficients

TG 105: Water Solubility

TG 107: Partition Coefficient (n-octanol/water): Shake Flask Method

TG 116: Fat Solubility of Solid and Liquid Substances

TG 117: Partition Coefficient (n-octanol/water): HPLC Method

TG 123: Partition Coefficient (n-octanol/water): Slow-Stirring Method

Interfacial, Soil, & Solution Chemistry

TG 106: Adsorption — Desorption Using a Batch Equilibrium Method

TG 111: Hydrolysis as a Function of pH

TG 112: Dissociation Constants in Water

TG 115: Surface Tension of Aqueous Solutions

TG 121: Estimation of the Adsorption Coefficient (\(K_{oc}\)) on Soil and on Sewage Sludge using HPLC

TG 122: Determination of pH, Acidity and Alkalinity