Hasil Pencarian  ::  Simpan CSV :: Kembali

Abstrak :
Laporan magang ini bertujuan untuk mengevaluasi prosedur pengujian substantif yang dilakukan oleh KAP Alba & Rekan untuk akun beban operasional PT Health yang merupakan sebuah perusahaan yang bergerak di industri produk konsumen (consumer product) bidang kesehatan. Evaluasi dilakukan terhadap prosedur pengujian asersi manajemen, prosedur substantif, bukti audit, konfirmasi eksternal, sampling, dan dokumentasi yang dilakukan oleh KAP Alba & Rekan. Adapun hasil evaluasi menunjukkan bahwa seluruh prosedur yang dilakukan oleh KAP Alba & Rekan telah sesuai dengan pedoman yang berlaku yakni Standar Audit (SA) Revisi 2021. ......This internship report aims to evaluate the substantive testing procedures carried out by KAP Alba & Rekan for the account operating expense of PT Health, which is a company engaged in the health consumer product industry. Evaluation is carried out on management assertion testing procedures, substantive procedures, audit evidence, external confirmation, sampling, and documentation carried out by KAP Alba & Rekan. The evaluation results show that all procedures carried out by KAP Alba & Rekan are in accordance with the applicable guidelines, namely Auditing Standards (SA) Revisi 2021.

Abstrak :
Compatibility of pharmaceutical products and contact materials helps pharmaceutical, toxicology, analytical, and regulatory affairs professionals assess the safety of leachable and extractable chemicals associated with drug product packaging, manufacturing systems, and devices. The most comprehensive resource available, its coverage includes the strategies, tactics, and regulatory requirements for performing safety assessments, along with the means for interpreting results. Structured around a logical framework for an extractables and leachables safety assessment and closely linked to the pharmaceutical product development process, Compatibility of Pharmaceutical Products and Contact Materials directly addresses the fundamental questions of "what activities need to be performed to completely, efficiently, and effectively address the issue of product safety from an extractables and leachables perspective?" and "when do the various required activities need to be performed?" Specifically, the chapters describe : - Pertinent regulations and practical ways to meet guidelines - Coordinating manufacturing, storage, and delivery systems development and qualification with therapeutic product development - Materials characterization and the materials screening process - Component and/or system qualification (illustrated by several case studies) - Performing validation/migration studies and interpreting and reporting the results - Creating a product registration dossier and putting it through regulatory review - Product maintenance (Change Control) from an extractables and leachables perspective - Likely future developments in extractables and leachables assessment Additionally, the book's appendix provides a database, including CAS registry numbers, chemical formulas and molecular weights of extractable/leachable substances that have been reported in the chemical literature.

Abstrak :
This book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance. This book explains six strategies to cost-effectively comply with FDA regulations while maintaining product safety and improving public access through cost controls. It provides useful and practical guidance through industry case studies from pharmaceutical, biotech, and medical device industries.