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GMP News Overview 2003

Nr.	Date	Title
371	12.12.2003	FDA Develops Quality Systems Guidance (Labcompliance News from Dr Ludwig Huber)
370	11.12.2003	Adjustment versus Modification - Interpretation of the Ph.Eur. Requirements
369	10.12.2003	ICH Q8 and ICH Q9 Coming Soon!
428	01.12.2003	6th APIC 2003
365	14.11.2003	EMEA Plans Revision of the Note for Guidance on Plastic Primary Packaging Materials
364	13.11.2003	Current Inspection Findings of the British Supervisory Authority MHRA (Formerly MCA)
355	20.10.2003	FDA Requirements on the Qualification of Component Suppliers
353	13.10.2003	New PIC/S Guidance on Computer Validation
351	22.09.2003	Analysis of Our Internet Survey of 28 August 2003
348	18.09.2003	First Consequences for Process Validation and Equipment Qualification According to the New FDA Draft Guidance on Aseptic Processing
347	08.09.2003	FDA Draft Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing
346	08.09.2003	Final Version: Guidance for Industry, Part 11, Electronic Records; Electronic Signatures - Scope and Application
345	08.09.2003	NEW: PAT (Process Analytical Technology) Draft Guidance from FDA!
339	28.08.2003	Is it possible to fulfil the new requirements of the revised Annex 1 to the EC Guide on the Manufacture of Sterile Medicinal Products?
340	27.08.2003	FDA's Expectations on the Training Documentation of Laboratory Staff
341	26.08.2003	Insight into the New ISPE Guide: "Assessing the Particulate Containment Performance of Pharmaceutical Equipment"
335	06.08.2003	Will the GMP Regulations Be Harmonised Worldwide?
330	22.07.2003	Heidelberg - an Attractive Conference Venue with Optimal Accessibility via Frankfurt
329	21.07.2003	FDA's System-based Approach to Inspections as Reflected in the Warning Letters
328	18.07.2003	Commission Directive 2003/63/EC: The New Annex 1 to Directive 2001/83/ EC
321	18.06.2003	FDA Presents Its Analysis of Observations Noted on 483 Forms
318	17.06.2003	Batch Release and Certification in the European Context - The MRA between Europe and Switzerland
316	16.06.2003	CPMP Guideline on NIR Adopted
315	20.05.2003	New Release: GMP Navigator on CD-ROM 5.0
311	02.05.2003	VDI Guideline 2083 Sheet 8 "Cleanroom Suitability of Operating Materials"
310	30.04.2003	Changes in the Application Form for a Marketing Authorisation
309	29.04.2003	FDA's Risk-based Approach - Tools for Risk Analysis
301	04.04.2003	Risk Classification of GMP Deviations
300	03.04.2003	Annual Review 2002
299	02.04.2003	Warning Letters 2002: The Top 10 Complaints Regarding 21 CFR § 211
294	26.02.2003	FDA Withdraws All Part 11 Guides and Publishes a New Draft
293	25.02.2003	MRA between EU and Canada Came into Force on 1 February 2003!
292	24.02.2003	Revision of the PIC/S Document PH 4/93 on the Preparation of a Site Master File
289	17.02.2003	ISPE's White Paper on "Risk-Based Approach to 21 CFR Part 11"
288	15.02.2003	Revision of the EMEA Guideline on Stability Testing of Existing Active Substances and Related Finished Products
287	14.02.2003	FDA Withdraws Part 11 Guide!
282	03.02.2003	Social Events
278	13.01.2003	PIC/S Recommendation on Sterility Testing Revised
277	10.01.2003	HPLC in FDA Warning Letters