GMPSOP

AUGUST 28, 2023

This article is crafted with real-life experiences and insights to help you fine-tune your material handling processes, optimize efficiency, and ensure compliance while working at the warehouse. – The material can be identified correctly on the label, and – The correct quantity, according to the purchase order.

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Health and Personal Care Stores Labelling Packaging Documentation 52

Safe Biologics

DECEMBER 6, 2023

REMINDER: FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert. Read the full BioSpace article here.

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GMPSOP

NOVEMBER 15, 2024

Stability testing ensures that the manufactured products remain safe, pure, and effective throughout their shelf life if they are kept in specified packaging and under environmental conditions. They are necessary for the API testing method and will also have to be conducted for the formulated and packaged product.

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Packaging Dosage Documentation Labelling 59

National Association of Boards of Pharmacy

APRIL 10, 2024

Then, walk through each step of the practice of pharmacy such as data entry; drug utilization review; compounding; final association between the drug, the prescription, and the label (eg, the dispensing act); and patient counseling. Go through each step in the process until the prescription is picked up, mailed, or delivered to the patient.

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GMPSOP

FEBRUARY 15, 2024

This article is to help all personnel maintain a state of alertness to make sure that the plant housekeeping is always kept at the peak of efficiency. They should place all discarded cardboard, paper, and corrugation from the Packaging Dept. Quality assurance inspectors destroy all unused labels and inserts from the Packaging Lines.

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Documentation Labelling Compounding Packaging 52

GMPSOP

SEPTEMBER 22, 2022

Acceptable Quality Limit is used to make an informed decision whether to accept or reject an incoming packaging components lot by assessing the lot size and types of defects found during a pre-determined level of inspection. 4.0%) A defect that is not likely to materially reduce the usability of the product for its intended purpose.

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Packaging Documentation Labelling 52

FDA Law Blog: Biosimilars

JANUARY 3, 2024

Specifically, CVM ensures that animal drugs are safe and effective, properly made, and adequately labeled and packaged; food-producing animals only take drugs that would be safe for humans to consume; pet foods and additives are safe; and educates the public, monitors the market, and encourages development of new animal health products.

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Packaging Labelling Vaccines 57

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.

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Compounding Sterile Compounds Packaging Labelling 52

FADIC

JULY 14, 2024

OTC drugs come in various forms, including tablets, capsules, creams, and liquids, and are generally labeled with clear instructions on proper usage and dosage. The FDA’s website provides a wealth of information on OTC drugs, including product labels, warnings, and recalls.

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Adverse Reactions Dosage Mayo Clinic Medical Schools 105

European Pharmaceutical Review

FEBRUARY 23, 2023

This article presents an overview of Raman spectroscopy and details some of the developments of interest to the pharmaceutical sector. 11 Future methods are likely to require samples being collected, labelled, filtered and processed to obtain their spectra. Label-free, rapid and quantitative phenotyping of stress response in E.

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Labelling Packaging Drug Development 121

European Pharmaceutical Review

SEPTEMBER 2, 2022

This article explores just one aspect of the RMP, that of RMMs, and how their effectiveness is measured with Dr Sophie Jouaville, an associate principal at IQVIA working on the design and oversight of non-interventional real-world evidence (RWE) safety and health economics and outcomes research (HEOR) studies.

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Adverse Reactions Documentation Medical Schools Packaging 96

GMPSOP

JUNE 28, 2024

Packaging/labeling/Misbranding: 41 warnings vi. Similarly, the packaging, labeling, and misbranding-related warning letters were the top reasons in 2019. This article will explore more elements of unplanned deviations than planned deviations. CGMP Deviation: 39 warnings ii. Adulterated API: 39 warnings iv.

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Documentation Packaging Labelling Pharmaceutical Manufacturing 59

GMPSOP

OCTOBER 28, 2023

Packaging material specifications In the pharmaceutical industry, the requirements for pre-printed packaging materials must be well-defined and documented to ensure that you get the items you specified or ordered and that there are no mix-ups. A standard name and a unique item code define packaging materials.

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Birth Control Pharmacist

SEPTEMBER 20, 2021

While not stated in the current package insert, data are emerging that support fewer breast tissue effects and breakthrough bleeding than older oral contraceptives. Nextstellis (Drospirenone and Estetrol) [package insert]. Available at: www.accessdata.fda.gov/drugsatfda_docs/label/2021/214154s000lbl.pdf. Accessed June 25, 2021.

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Adverse Reactions Packaging Labelling Diabetes 52

The Thyroid Pharmacist

JULY 29, 2022

In this article, you will learn: How we are exposed to unhealthy air quality, indoors and outdoors. Perhaps more concerning, of the 133 different VOCs found across all tested products, only one, ethanol, was actually listed on any label! (13, For sunscreens and other over-the-counter drugs, fragrances must be identified on the label.

Health and Personal Care Stores 52

Health and Personal Care Stores Compounding Immunity Immunization 52

GMPSOP

MAY 31, 2024

This article can help you understand who is responsible for preparing the validation master plan, the stages of the validation life cycle, the risk-based prioritization of validation items, how to prepare a validation schedule, and some practical examples. The process validation of formulated products (e.g., tablets, capsules, ointments, etc.)

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GMPSOP

JULY 23, 2023

If you are completely unfamiliar with what is installation qualification then we suggest you read the article Validation in Pharmaceutical Industry first. If you would like to know more on how to prepare acceptance criteria to use using verification of common pharmaceuticals equipment please read our article on operational qualification.

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Documentation Method Validation Packaging Labelling 52

GMPSOP

MARCH 17, 2023

Table of Contents If you are looking for literary help to write an actionable procedure on corrective and preventive action for your workplace or school, this article will be a good place to start. Further to corrective action, the defective packaging (carton) lot was destroyed which was initially quarantined. Consider this scenario.

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Documentation Packaging Process Improvement Pharmaceutical Manufacturing 52

GMPSOP

JULY 14, 2023

In this article, we will discuss important aspects of equipment cleaning that are required during pharmaceutical manufacturing. Equipment cleaning validation protocol was not discussed intensely in this article which was covered elsewhere in this blog. They should never be topped up, used, or stored without labels and expiry dates.

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Documentation Labelling Pharmaceutical Manufacturing Packaging 52

The Thyroid Pharmacist

NOVEMBER 11, 2022

In this article, I share some fun ideas for gifts you can give (or add to your own wishlist ;-)). Check out my article on How Adaptogenic Herbs Benefit Hashimoto’s to learn more.). It turns out that many of the ingredients in laundry detergent aren’t listed on the label (and can irritate one’s skin!), The foodie.

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Labelling Packaging 98

GMPSOP

JULY 31, 2023

In this article, we will explore what operational qualification entails, its importance, and FDA requirements. – High-Speed Tablet/Capsule Counting Machines (Critical for accurate counting and packaging of tablets and capsules). 90% to 110% of the label claim). 5% of the average force).

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Documentation Dosage Labelling Data Entry 52

The Thyroid Pharmacist

AUGUST 19, 2022

In this article, I’ll dive a little bit deeper into: How infections can act as Hashimoto’s triggers. 2-5) I’ll share more about this later in this article, but for now, I wanted to mention that this is why I look at hundreds of studies and patient cases before I dismiss a trigger after just one study. pylori affects Hashimoto’s.

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Health and Personal Care Stores Immunity Immunization Dosage 98

The Thyroid Pharmacist

SEPTEMBER 6, 2023

You can learn more about infrared sauna contraindications on Sunlighten’s website , as well as in my article on Saunas and Hashimoto’s here. Personal Care : The Wellnesse line of haircare and toothpastes by Katie Wells (aka the “Wellness Mama”) contains high-quality, safe ingredients that are clearly labeled, so there are no surprises!

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Health and Personal Care Stores Packaging Compounding Labelling 81

The Thyroid Pharmacist

OCTOBER 27, 2023

3] You can learn more about the HPA axis and adrenals here in the linked article. Follow package instructions. Follow package directions for each supplement. Precautions Do not take more than the recommended dose on the label. I hope that you will find this information helpful for you and your family!

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Pharma in Brief

JANUARY 9, 2022

In this article, the Pharma in Brief team has curated and provided updates on the most significant topics we covered in 2021. Health Canada also consulted on proposed guidelines for the use of electronic media in prescription drug labelling (see here ). Introduction.

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Documentation Labelling Vaccines Packaging 52

pharmaphorum

MAY 26, 2022

Certain groups of individuals may then not trust that the medicines have been produced with them in mind and may be highly sceptical of the resulting evidence base and prescribing label of medicines. As a Non-Clinical Assessor at MHRA he assessed non-clinical data packages for new and generic medicines. About the authors.

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