AROUND LAB NEWS / IT » Metodi Farmaceutici

Pharmacopeial Forum Vol. 40 No.5: Sep – Oct 2014

AROUND LAB NEWS / IT — Thu, 02 Apr 2015 13:25:08 +0000

A new edition of the Pharmacopeia Forum has been issued. Among the items of interest are:

Chapter 1041 - Biologics (Revision proposal target, USP38-NF33 2nd Supplement)

USP propose revision of this General Chapter to update definitions, references and to explain compendial requirements and perspectives pertaining to this class of products and future monographs. Chapter <1041> is cross-referenced in the following general chapters and monographs.

General Notices, 5.50.10 Units of Potency (Biological). These citations will remain as written when the revised chapter text becomes official.

Chapter 1207 - Sterile Product Packaging – Integrity Evaluation (Revision proposal target, USP38-NF33 2nd Supplement)

Chapter 1207 has been extensively revised and subdivided into four related chapters.

1207.1 - Package Integrity and Test Method Selection [NEW]

(Revision proposal target, USP38-NF33 2nd Supplement)

This proposed new general chapter describes a range of package integrity test methods that are used for ensuring sterile package integrity. Different types of package defects that cause leaks are described, and information about their detection is provided. Limit of detection is discussed in detail for the different leak test methods.

1207.2 - Package Integrity Leak Test Technologies [NEW]

(Revision proposal target, USP38-NF33 2nd Supplement)

This proposed new general information chapter provides information guiding the selection and proper use of leak test technologies. These leak test methods are divided into two major categories: deterministic and probabilistic. For each leak test technology, the chapter provides a description and discusses applications, test equipment, and test parameters.

1207.3 - Package Seal Quality Test Methods [NEW]

(Revision proposal target, USP38-NF33 2nd Supplement)

This proposed new general information chapter summarizes test methods useful for characterizing and monitoring package seal quality. These methods are not leak tests but provide additional data regarding package seal characteristics that may affect package integrity and leakage. The purpose of this chapter is to provide information to guide the selection and use of package seal quality test technologies.

1210 - Statistical Tools for Procedure Validation [NEW]

(Revision proposal target, USP38-NF33 2nd Supplement)

A new general information chapter is proposed as a companion chapter to Validation of Compendial Procedures, <1225> with the purpose of providing statistical methods that can be used in the validation of analytical procedures.

Fonte >>>

I metodi analitici adottati dai laboratori europei delle Dogane

AROUND LAB NEWS / IT — Wed, 28 Jan 2015 17:34:37 +0000

Action 1 of the Group of European Customs Laboratories:

ILIADe, Inter Laboratory Inventory of Analytical Determination

Database of analytical methods

ILIADe is a shared directory of the analytical methods initially developed by the Italian Customs Agency and currently hosted by the European Commission. Its main purpose is to improve the effectiveness of Customs Laboratories by providing them with an easily accessible and up-to-date compilation of analytical methods they are required to use for Customs purposes, as well as for authenticity and quality controls, consumer health protection and environmental controls. The database contains official analytical methods, international standards and in-house developed methods.

ILIADe is accessible to the Customs Laboratories from the Member States and the list of methods and contacts is also available on special request to third countries. An inquiry function, with several fields available, provides the possibility of searching for an analytical method.

The ILIADe database content is discussed and validated by a dedicated working group.

Links exist between the different actions led by the Customs Laboratories European Network, for example, Action 2 activities (Inter-comparisons and method validations studies) often result in validated methods that will be included in the ILIADe database later.

Screenshot of the Search for Methods screen:

Sample preparation selection

AROUND LAB NEWS / IT — Wed, 29 Jan 2014 08:56:06 +0000

With the increasing awareness of food safety in both developed and developing countries, analysis of a variety of imported and exported commodities is a priority concern for the national competent authorities. Sample preparation of foods such as vegetables, fruits, dairy, and meats followed by downstream high-pressure liquid chromatography (HPLC), liquid chromatography with tandem mass spectrometry (LC/MS/MS), or gas chromatography with mass spectrometry (GC/MS) analysis is a practice that helps ensure the safety of consumers

Fonte: Food Quality and Safety

Sampling Plans: PDA Technical Books

AROUND LAB NEWS / IT — Wed, 27 Nov 2013 15:35:18 +0000

The Square Root of (N) Sampling Plans: Procedures and Tables for Inspection of Quality Attributes presents technical and practical information for the correct use of the three sqrt (N) attribute sampling plans.

While the book is oriented to the domestic and international pharmaceutical industry, the material is general enough to be adapted to other industries and applications.

Link >>>

Sampling Plans

AROUND LAB NEWS / IT — Mon, 22 Jul 2013 13:16:06 +0000

Square Root of (N) Sampling Plans: Procedures and Tables for Inspection of Quality Attributes

By Lynn Torbeck and Joyce Torbeck
Shows that the sqrt (N) plans are statistically correct and can be used in applications that minimize risk to the patient. Technical and practical information for the correct use of the three sqrt attribute sampling plans is presented.
Pre-order and save 20% through July 31. Enter campaign code SRNSP to apply discount during checkout.
PDA Member: $210 $168|Nonmember: $259 $207.20|Government: $170 $136

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Lal Test

AROUND LAB NEWS / IT — Mon, 08 Jul 2013 08:42:47 +0000

EndoLISA® Endotoxin Detection based on ELISA Technology

www.hyglos.de

Novità Legislative e Normative

AROUND LAB NEWS / IT — Mon, 27 May 2013 13:26:56 +0000

EMA

Annexes to: CMPM/ICH/283/95 Impurities: Guideline for residual solvents

Guide line on the declaration of the quantitative composition/labeling of biological medicinal products that contain modified proteins as active substance

Concept paper on the need for a reflection pqper on quality aspects of medicines for older people.

Importation of active substances for medicinal products for human use – Q&A ver 4.0.

Human Pharmaceutical Committee Maeeting of March 27, 2013

Guidelines on the principles of Good Distribution Practices for Active Substances for Medicinal Products for Human Use.

FDA

Recommendations for Labelling Medicinal Products to inform users that the product or product container is not made with natural rubber latex

Glass syringes for delivering drug and biological products technical information to supplement intenational organizations for Standardization (ISO) Standard 11040-4

Tablet scoring. Nomenclature, Labeling and Data for Evaluation

ANVISA

Validacao de limpeza para farmoquimica.

PDA

Technical Report on Process Validation.

Metodi Analitici Farmaceutici – Analisi dei farmaci

AROUND LAB NEWS / IT — Mon, 13 May 2013 16:10:03 +0000

Analisi qualitativa e quantitativa

Stefania Villa. Università di Milano

Fonte: Link >>>

Aggiornamento norme sul campionamento materie prime di medicinali

AROUND LAB NEWS / IT — Thu, 02 May 2013 08:22:05 +0000

L’AIFA (Agenzia Italiana del Farmaco), con la determinazione AIFA n.26/GC/PCA/DG del 21 Dicembre 2012, ha aggiornato la normativa italiana sul campionamento delle materie prime farmacologicamente attive e eccipienti utilizzati nella produzione di medicinali.

- www.agenziafarmaco.gov.it

Aggiornamento norme sul campionamento materie prime di medicinali

AROUND LAB NEWS / IT — Fri, 12 Apr 2013 08:57:33 +0000

http://www.agenziafarmaco.gov.it/it/content/determinazione-aifa-su-modalit%C3%A0-di-campionamento-delle-materie-prime-farmacologicamente-at-0