European Pharmaceutical Review

AUGUST 23, 2022

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

Documentation 105

Documentation Pharmaceutical Manufacturing Packaging Labelling 105

European Pharmaceutical Review

FEBRUARY 23, 2023

11 Future methods are likely to require samples being collected, labelled, filtered and processed to obtain their spectra. Adv Appl Microbiol 2010; 70:153–186 Teng L, et al. Label-free, rapid and quantitative phenotyping of stress response in E. Eng Life Sci; 2010; 10:422–429 De Marchi S, et al. link] Huang WE, et al.

Labelling 121

Labelling Packaging Drug Development 121

RX Note

MARCH 23, 2023

Today, stability information can be obtained from manufacturer’s labelling information (such as in the package insert), the USP compounding monographs, or peer-reviewed articles and references , such as articles in American Journal of Health-System Pharmacy, the International Journal of Pharmaceutical Compounding.

Compounding 52

Compounding Sterile Compounds Packaging Labelling 52

Pulses

AUGUST 31, 2023

Chandos Publishing; 2010:123-168. References Ley D, Parkes D, Walton G. 6-emerging technologies for learning. Web 20 and Libraries. Hamilton D, McKechnie J, Edgerton E, Wilson C. Immersive virtual reality as a pedagogical tool in education: a systematic literature review of quantitative learning outcomes and experimental design.

Medication Dispensing 78

Medication Dispensing Medication Labelling Packaging Labelling 78

Syner-G

AUGUST 9, 2022

In 2010, following a referral from another company, IMPACT (now part of Syner-G BioPharma Group) was contacted by a mid-size biopharmaceutical company to assist them with an upcoming NDA for a new chemical entity in the treatment of an orphan condition. Download a PDF of this case study. The Journey Leading to an Approved NDA.

Documentation 40

Documentation Packaging Labelling 40

RX Note

JUNE 5, 2023

A simple method is to use a small adhesive label to mark the position and thus produce a measure with just one graduation.) Furthermore, in late August 2020, the FDA approved labelling changes for hydrochlorothiazide (HCTZ) to inform clinicians and patients about the slight risk of developing non-melanoma skin cancer.

Compounding 52

Compounding Labelling Packaging Hospitals 52

RX Note

JULY 14, 2023

Moreover, even after the MDI delivers the number of puffs stated on their label, it may look, taste and feel like it is still working, but the dose delivered may be very low. Handling of Inhaler Devices, 2010 suggested that re-priming should be done for MDIs that are not used for more than 2 weeks. suds intact).

Packaging 52

Packaging Labelling 52