عنوان

Solid oral dose process validation :

شابک

3030024725

شابک

9783030024727

شابک اشتباه

9783030024710

عنوان اصلي

Solid oral dose process validation :

نام عام مواد

[Book]

ساير اطلاعات عنواني

the basics.

نام نخستين پديدآور

Ajay Babu Pazhayattil, Naheed Sayeed-Desta, Emilija Fredro-Kumbaradzi, Jordan Collins.

مشخصه جلد

Volume 1 /

محل نشرو پخش و غیره

Cham, Switzerland :

نام ناشر، پخش کننده و غيره

Springer,

تاریخ نشرو بخش و غیره

[2018]

تاریخ نشرو بخش و غیره

©2018

نام خاص و کميت اثر

1 online resource

عنوان فروست

AAPS introductions in the pharmaceutical sciences

متن يادداشت

Includes bibliographical references and index.

متن يادداشت

Volume One. Preface -- Lifestyle Approach to Validation -- Solid Dose Formulations -- Stage 1A Process Design: Quality by Design -- Knowledge Management and Risk Assessment for Lifestyle Stages -- Stage 1B Process and Scale Up Considerations -- Stage 2A and 2B Process Qualifications -- Stage 3A and 3B: Continued Process Verification.

بدون عنوان

0

متن يادداشت

Currently there are no process validation (PV) textbooks addressing the lifecycle concepts (Stage 1, 2, 3). Recent regulatory guidance's such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. The concepts are now harmonized across regulatory guidance's and organizations have an opportunity to align PV activities for all regulated markets. Therefore a need exists for consensus and direction on how to approach solid dose manufacturing process validation for regulatory compliance. Solid Dose Process Validation: The Basics, Volume One and companion Solid Dose Process Validation: Lifecycle Approach Application, Volume Two, also available as a set, provide directions and solutions for these unmet needs for the pharmaceutical industry. The topics and chapters give a systematic understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. All approaches meet the regulatory requirements enlisted in the guidance's, which is the precursor to applying the concepts. This set is published as a comprehensive solution for solid dose process validation. Since solid dose formulations encompass majority of the pharmaceutical preparations, it is essential information for pharmaceutical professionals who use the process validation lifecycle approach.

منبع سفارش / آدرس اشتراک

Springer Nature

شماره انبار

com.springer.onix.9783030024727

موضوع مستند نشده

Drugs.

موضوع مستند نشده

Pharmaceutical chemistry.

موضوع مستند نشده

Pharmaceutical technology.

موضوع مستند نشده

Solid dosage forms.

موضوع مستند نشده

Drugs.

موضوع مستند نشده

MEDICAL-- Pharmacology.

موضوع مستند نشده

Pharmaceutical chemistry.

موضوع مستند نشده

Pharmaceutical technology.

موضوع مستند نشده

Pharmaceutical technology.

موضوع مستند نشده

Pharmacy-- dispensing.

موضوع مستند نشده

Solid dosage forms.

موضوع مستند نشده

MED-- 071000

شماره

ويراست

شماره رده

مستند نام اشخاص تاييد نشده

Pazhayattil, Ajay Babu

مستند نام اشخاص تاييد نشده

Collins, Jordan

مستند نام اشخاص تاييد نشده

Fredro-Kumbaradzi, Emilija

مستند نام اشخاص تاييد نشده

Sayeed-Desta, Naheed

تاريخ عمليات

20200823074238.0

قواعد فهرست نويسي ( بخش توصيفي )

pn

نام الکترونيکي

نوع ماده

[Book]

تكميل شده

Y