GMP LOGFILE Features - Archive

Quarter 02/2018

PQ-Qualification-Validation.pdf

Practical-Issues-Supply-Chain-Good-Distribution-Practice.pdf

LOGFILE-19-Regulations-Report.pdf

Annex1-ISPE-Conference-Part2.pdf

Layout-Cleanroom-Air-Unit.pdf

Pharma4.0-ISPE-Conference-Part1.pdf

Principles-of-Qualification.pdf

Dialogue-AuditsInspektions-Part-2.pdf

Dialogue-AuditsInspections-Part-1.pdf

Quarter 01/2018

Sampling-Frequencies.pdf

QP-Cleaning-Validation-Part2.pdf

QP-Cleaning-Validation-Part1.pdf

General-Principles-Hygienic-Design.pdf

Annex-1-Part-2.pdf

Annex-1-Part-1.pdf

Root-Cause-Analysis_An-Essential-Enabler.pdf

Implementing-Monitoring-Data-Integrity-Measures.pdf

Serialisation-Projects-Part-2.pdf

Serialisation-Projects-Part-1.pdf

Risk-Analysis-Equipment-Life-Cycle.pdf

Ask-Our-Experts-Part2.pdf

Quarter 04/2017

Ask-Our-Experts-Part1.pdf

International-GMP-Morenas.pdf

PDE-Study.pdf

EMA-QA-WFI.pdf

Mobile-Water-Treatment.pdf

Quarter 03/2017

MHRA-annual-deficiency-review-part2.pdf

MHRA-annual-deficiency-review-part1.pdf

Data-Integrity-Part2.pdf

Data-Integrity-Part1.pdf

MRA-EU-USA-Part2.pdf

MRA-EU-USA-Part1.pdf

ISPE-2017.pdf

Quarter 02/2017

PDA_Annual_Meeting_2017.pdf

USP-1231.pdf

Quality-Agreement_page1and3.pdf

GMP-Questionnaire_page2.pdf

Data-Integrity-is-a-Must_.pdf

Technical-Agreement-and-Delimination.pdf

Formalizing_a_Risk_Assessment_for_Excipients.pdf

GMP-Supplier-Assessment-Questionnaire.pdf

Comment-EMA-Concept-Paper.pdf

Quarter 01/2017

Access-for-inspectors-auditors_QA.pdf

Review-2016.pdf

Self-Inspection_QA.pdf

PDE-Part2.pdf

PDE-Part1.pdf

Quarter 04/2016

Quality-Metrics-Dialogue4-EN.pdf

PDA-FDA-JRC2016_EN.pdf

Quarter 03/2016

Interview_EMA_QA_WFI_Roeder.pdf

Achieving-Quality-beyond-Compliance.pdf

Separate-Device-Specification-FDA.pdf

Don_t_Be_a_Daredevil_When_Retrofitting_Your_Facility.pdf

Basic-Principles-of-DMS.pdf

Quarter 02/2016

EN-Change-control.pdf

USP1231_EN.pdf

Qualification-of-Single-Use-Component.pdf

Quality_Metrics.pdf

GDP-Checklist-Warehousing.pdf

Quarter 04/2014

GMP-certificates.pdf

EDMF-ASMF-CEP.pdf

saftey-in-the-workplace.pdf

Quarter 03/2014

Integrated-QRM.pdf

Human-Resource-Management.pdf

Risk_Assessment.pdf

Electronic-Training-Systems.pdf

Quarter 02/2014

Quality_Assurance.pdf

Knowledge-Management.pdf

EU-GMP-Guide-revisions.pdf

Quality-Culture.pdf

Cross-Contamination.pdf

Packaging.pdf

Quarter 01/2014

How_to_master_crisis_situations.pdf

Risk-Management-in-Transport.pdf

Investigations.pdf

GDP-Checklist-Warehousing.pdf

Fight-Against-Counterfeit-Medicines.pdf

What-To-Expect-2014.pdf

Quarter 04/2013

Risk-Management-For-Computerized-Systems.pdf

Preparing-GMP-Inspections.pdf

Process-Validation-Trends.pdf

Quality-Agreements-PartII-TP.pdf

Quality-Risk-Management.pdf

Excipients.pdf

Quality-Agreements.pdf

GMP-Audit-Checklist.pdf

PDA-FDA-final.pdf

Quarter 03/2013

Transport-of-Drugs.pdf

Principles-of-Change-Control.pdf

Audit-Procedures.pdf

Technical-Report.pdf

Quarter 02/2013

Drugmakers-and-Contractors.pdf

Deviations-Definition-Requirements.pdf

Quarter 01/2013

PQR-AQR.pdf

Gmp-Relevant-Documents.pdf

Coding-and-Serialisation.pdf

EU-GMP-Guidelines-2013.pdf

Improve-Quality-Systems-Part2.pdf

Improve-Quality-Systems-Part1.pdf

Good-Practices-For-Microbiology-Labs.pdf

Quarter 04/2012

Comparing-Annex-II-EU-v3.pdf

Change_Management.pdf

Comparison-EU-Chapter1-v2.pdf

Quarter 03/2012

Good-Distribution-Practice-GDP.pdf

Electronic-Records-Audit-Questions.pdf

Contract-Mnufacturer-Agreement.pdf

Laboratory-Controls-Audit-Questions.pdf

Quarter 02/2012

Top10-GMP-Deficiencies.pdf

Site-Master-File-guidelines.pdf

PDA_Annual_Meeting-engl-final.pdf

transfer-of-qualification-activities-to-suppliers-final.pdf

the-v-model.pdf

risk-analysis-ra2x5-final.pdf

EMA-process-validation-draft-v3.pdf

importance-of-commenting-on-public-standards.pdf

usp-and-ipec-GDPs-for-excipients.pdf

Quarter 01/2012

medical-devices-customer-complaints.pdf

the-new-quality-paradigm.pdf

monitoring-of-hvac-systems.pdf

quality-requirements-for-pure-steam.pdf

gmp-guidelines-2012.pdf

main-elements-of-a-PQS.pdf

contract-manufacture.pdf

Quarter 04/2011

risk-assessment.pdf

temperature-profiles-tp-jr.pdf

gmp-review_news__63_Oct_11.pdf

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