Challenges in AAV manufacturing: the interplay of process variations, in-process characterization, and drug product quality

Annual Product Quality Review (APQR) is an estimation prepared according to the Current Goods Manufacturing Practice (CGMP) requirements of different regulatory authorities. A Goods Manufacturing Practice (GMP) ensures that the products are constantly produced and controlled according to quality standards. APQR is not only required for GMP but also required for the quality improvement of the pharmaceutical product. APQR is an evaluation carried out annually to measure the standard of quality of each drug with an intention to verify the constancy of current process and to check the correctness of current specifications and to highlight any trend in order to determine the need to change any drug product specifications or the manufacturing processes or control procedures. It is a written report that is required for every drug, based on the data that was collected in the previous year. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the finished product. The APQR is globally accepted by the industry and the contents should specify a list of manufactured batches, release data and reviews of deviations, complaints, recall and returned goods. This article gives brief overview of regulatory aspects and regulatory requirements for Annual Product Quality Review of pharmaceutical product. It mainly focusses on the documentation required for the preparation of Annual Product Quality Review. Thus the article is based on the regulatory requirements or standards to manufacture and maintain the quality of any pharmaceutical product.

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A Biopharmetrics Approach for Drug Product Quality Control with Clinical Relevance

Journal of Pharmaceutical Sciences ◽

10.1016/j.xphs.2020.08.005 ◽

2021 ◽

Vol 110 (1) ◽

pp. 478-488

Author(s):

John Z. Duan

Keyword(s):

Quality Control ◽

Product Quality ◽

Clinical Relevance ◽

Drug Product ◽

Product Quality Control

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Improved Morphine-Loaded Hydrogels for Wound-Related Pain Relief

Pharmaceutics ◽

10.3390/pharmaceutics11020076 ◽

2019 ◽

Vol 11 (2) ◽

pp. 76 ◽

Cited By ~ 10

Author(s):

Dinis Mateus ◽

Joana Marto ◽

Patrícia Trindade ◽

Humberto Gonçalves ◽

Ana Salgado ◽

...

Keyword(s):

Product Quality ◽

Drug Product ◽

Assessment Approach ◽

Product Profile ◽

Product Quality And Safety ◽

Semi Solid ◽

Definition Of ◽

Franz Diffusion Cells ◽

Prolonged Drug Release ◽

Morphine Hydrochloride

The use of morphine applied topically to painful wounds has potential advantages, such as dose reduction, fewer side effects and compound formulations, have been proposed for this purpose. Given the potential high impact of drug product quality on a patient’s health, the aim of the present study was to develop two stable sterile hydrogels containing morphine hydrochloride, intended for topical application on painful wounds. Two carboxymethylcellulose sodium-based hydrogels were prepared containing 0.125% w/w (F1-MH semi-solid formulation) and 1.0% w/w (F2-MH fluid formulation) morphine hydrochloride (MH), respectively. Studies included a risk assessment approach for definition of the quality target product profile (QTPP) and assessment of critical quality attributes (CQA) of the hydrogels to support product quality and safety. Safe, odourless, yellowish, translucent and homogeneous gels were obtained, with suitable microbiological and pharmaceutical characteristics. The active substance concentration was adapted according to the characteristics of the dose-metering device. Release profiles were investigated using Franz diffusion cells, and characterised by different kinetic models. Increasing gel viscosity prolonged drug release, with rates of 17.9 ± 2.2 μg·cm−2·h−1 (F1-MH) and 258.0 ± 30.4 μg·cm−2·h−1 (F2-MH), allowing for the reduction of the number of applications and improving patient compliance. The gels proved to be stable for up to 60 days at room temperature. The semi-solid and fluid MH-containing hydrogel formulations are safe, stable and suitable for use in hospital settings, which is rather important for wound-related pain management in cancer palliative care or burn patients.

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