AROUND LAB NEWS / EN » Methods Pharma

AIR, HANDS, SURFACES

AROUND LAB NEWS / EN — Mon, 12 Oct 2015 07:26:03 +0000

Where find useful information for the microbiological sampling of air, hands, surfaces (application notes, expert, methods, references, legislation, etc.)

Visit the WEB site “ The TRIO.BAS air samplers Family” WWW.AROUNDLABNEWS.COM

The analytical tests present inside the 6.6. Supplement of European Pharmacopeia

AROUND LAB NEWS / EN — Mon, 12 Oct 2015 07:24:51 +0000

Answer:

2.2.31	Electrophoresis
2.2.42	Density of solids
2.2.47	Capillary electrophoresis
2.2.54	Isoelectric focusing
2.2.55	Peptide focusing
2.2.56	Amino acid analysis
2.4.29	Composition of fatty oils rich in omega-3 acids
2.6.14	Bacterial endotoxins
2.6.17	Test or anti-complimentary activity of immunoglobulin
2.9.3.	Dissolution test for solid dosage forms
2.9.7.	Friability of uncoated tablets
2.9.37	Optical microscopy
2.3.2.	Identification of fatty oils by thin-layer chromatography
2.4.22	Composition of fatty acids by gas chromatography
5.1.3.	Efficacy of anti-microbial preservation

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

AROUND LAB NEWS / EN — Mon, 02 Mar 2015 11:53:35 +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 >>>

PDA Technical Report No. 33, Revised 2013 (TR 33) Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Methods

AROUND LAB NEWS / EN — Wed, 02 Apr 2014 16:34:09 +0000

Intended to provide guidance for the successful evaluation, validation, and implementation of alternative and rapid microbiological methods needed by the pharmaceutical, biotechnology and medical device industries to assure product quality. This technical report was written to establish industry-wide criteria on what constitutes an acceptable alternative or rapid microbiology test to the compendial or classical method and how to prove it to the satisfaction of quality organizations and regulatory agencies.

Fonte: PDA

PDA Technical Report 64 (TR 64): Active Temperature-Controlled Systems: Qualification Guidance

AROUND LAB NEWS / EN — Tue, 01 Apr 2014 16:32:31 +0000

TR-64 addresses best practices for qualifying temperature-controlled trucks or trailers, temperature-controlled ocean containers, active unit load devices and walk-in temperature-controlled stores that are used to quarantine, hold or store raw materials, intermediates or products.

The report also identifies best practices for performing and documenting the qualification activities, including temperature mapping studies that are part of an overall validation program.

pda@pda.org

Chromatography Techniques

AROUND LAB NEWS / EN — Thu, 19 Dec 2013 08:08:45 +0000

http://www.chromatographytechniques.com/

Sample preparation selection

AROUND LAB NEWS / EN — Wed, 18 Dec 2013 08:07:17 +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

LAL Test

AROUND LAB NEWS / EN — Mon, 27 May 2013 10:00:57 +0000

EndoLISA® Endotoxin Detection based on ELISA Technology

Link: www.hyglos.de

Standards Pharma news

AROUND LAB NEWS / EN — Thu, 02 May 2013 12:50:18 +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.

PET – Preservative effectiveness test

AROUND LAB NEWS / EN — Fri, 15 Mar 2013 09:50:57 +0000

Preservative Testing – Choice of Challenge Isolates – By Dr. Phil Gei

Font: Microbiologics. Pharmaceutical Micro Update. Volume 1 . Issue 2.

visit.microbiologics.com