pharmaphorum

JANUARY 28, 2021

For PRISYM ID client RxSource , a Global Clinical Trial Supplies Specialist, it means being ready to partner with sponsor companies to get everything set up for a clinical trial within a week, including packaging and labeling. This was an incredibly fast turnaround for what could easily have been a long and arduous onboarding process.

Labelling 52

Labelling Packaging Vaccines 52

FDA Law Blog: Biosimilars

AUGUST 17, 2023

Vanda requested that FDA revoke the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the generic tasimelteon products did not meet the statutory “same labeling” requirement for generic drugs found in 21 U.S.C. § Vanda’s Hetlioz was, in fact, the first FDA-approved drug product to include braille labeling.

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Labelling Packaging 40

Pharma in Brief

MARCH 18, 2021

Health Canada is seeking input from industry stakeholders on a new draft guidance document that discusses the use of electronic media in prescription drug labelling. A drug’s “label” can include its inner or outer labels, a package insert, or its product monograph ( PM ). Guidelines for electronic labelling.

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Labelling Documentation Packaging 40

GMPSOP

MARCH 3, 2024

Cross contamination in the pharmaceutical industry can be described as an accidental inclusion of product of another batch or unknown foreign material into a finished batch, which was not intended or not mentioned on the label. What are the examples of cross contamination in pharmaceutical industry?

Health and Personal Care Stores 52

Health and Personal Care Stores Packaging Labelling Documentation 52

European Pharmaceutical Review

NOVEMBER 24, 2022

Tackling pharmaceutical counterfeiting continues, therefore, to be a clear and present priority for manufacturers, healthcare authorities and law enforcement. One area in which the problem can be tackled effectively is product packaging. Quality assurances through the use of holograms.

Packaging 111

Packaging Labelling Documentation Dosage 111

GMPSOP

AUGUST 11, 2024

Documentation : Keeping detailed records of orders, specifications, manufacturing processes, packaging, and labeling to ensure traceability and compliance. Packaging and labeling operations for investigational products are often complex and must meet specific requirements to ensure the integrity of clinical trials.

Packaging 52

Packaging Documentation Labelling Dosage 52

GMPSOP

MARCH 30, 2024

Proper line segregation involves physically separating different lots of starting materials, labeling components, and printing matters, many of which look similar. Different products should not be packaged in proximity unless physical segregation exists. Please look at the labeling operation in the picture below.

Labelling 52

Labelling Packaging Documentation Pharmaceutical Manufacturing 52

European Pharmaceutical Review

JUNE 4, 2024

Solutions include washers, depyrogenating tunnels, liquid and powder filling and closing machines for vials, ampoules and Ready-To-Use (RTU), freeze dryers and relevant automatic loaders/unloaders, isolation technologies, labellers for vials and cartons and ancillary equipment.

Packaging 95

Packaging Customer Service Labelling Dosage 95

Pharma Marketing Network

AUGUST 9, 2023

Maintain a balanced approach by presenting both the benefits and potential risks of the medication or treatment. Adhere to Labeling and Packaging Requirements The labeling and packaging of pharmaceutical products are tightly regulated to ensure safety and accurate information.

Labelling 52

Labelling Packaging Communication Pharmaceutical Companies 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. ASBM surveys of U.S. However, S.6

Biosimilars 130

Biosimilars Packaging Labelling Drug Development 130

Safe Biologics

NOVEMBER 12, 2023

6 would prevent the HHS Secretary from requiring a switching study as part of the data package to receive the interchangeable designation. However, S.6 This would inappropriately limit the FDA’s authority to determine what data is scientifically appropriate for a particular biosimilar to provide in order to receive the designation.

Biosimilars 130

Biosimilars Drug Pricing Packaging Labelling 130

Pharma Marketing Network

AUGUST 9, 2023

Maintain a balanced approach by presenting both the benefits and potential risks of the medication or treatment. Adhere to Labeling and Packaging Requirements The labeling and packaging of pharmaceutical products are tightly regulated to ensure safety and accurate information.

Labelling 40

Labelling Packaging Communication Pharmaceutical Companies 40

Express Pharma

JUNE 28, 2024

With a focus on redefining the pharmaceutical industry in the post-COVID era, PharmaLytica 2024 offered a platform for stakeholders to engage in discussions covering the full spectrum of pharma machinery and packaging, lab analytical and cleanroom solutions, and pharmaceutical ingredients. trillion, with Turkey ranking 21st.

Packaging 100

Packaging Biosimilars Labelling Vaccines 100

European Pharmaceutical Review

MARCH 14, 2023

This concerns the quantity of the medicinal product in the packaging, ie, the increase or decrease in the number of units of the product in the outer packaging according to local demands and its labelling, including the leaflet, which should be in the language of the country into which the product is imported.

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Packaging Generic Medicine Labelling Pharmaceutical Companies 98

Eye on FDA

AUGUST 22, 2023

The Untitled Letter posted this week involved an oral birth control pill which has a specific of contraindications contained in the label as well as a list of warnings and precautions and of the most common adverse events. First, while presenting the indication in the posting, there was no risk information included in the communication.

Communication 68

Communication Packaging Labelling 68

ID Stewardship

OCTOBER 14, 2024

Read all about this in the product label here. More information on ganciclovir in the label here. The process is detailed in the package insert here. Also fun fact, IV SMX/TMP does not require refrigeration once mixed, so it gets a “DO NOT REFRIGERATE” sticker, at least that is more convenient. Well, maybe not.

Compounding 52

Compounding Labelling Packaging Hospitals 52

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.

Packaging 59

Packaging Dosage Documentation Labelling 59

GMPSOP

FEBRUARY 25, 2023

Starting materials are processed, sampled, tested, packaged, and released before the finished products are stacked on pharmacy shelves. Sampling is carried out on intermediate processed materials and tested to ensure those are formulated correctly, free from contamination and qualified for filling and packaging. as their visual aids.

Labelling 52

Labelling Packaging Documentation Pharmaceutical Manufacturing 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.

Packaging 52

Packaging Documentation Labelling 52

European Pharmaceutical Review

JANUARY 23, 2023

In addition, MSSG supports temporary national measures such as unit dose dispensing and compounding.

Packaging 98

Packaging Compounding Labelling Communication 98

FDA Law Blog: Biosimilars

JULY 10, 2023

We will then present an effective strategy to address FDA’s AI request in a timely manner. However, the strategy of addressing the AI request presented in the next section of this blog post applies to all three types of 510(k)s. For labeling documents and the 510(k) summary, FDA often requests both clean and redlined versions.

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Documentation Packaging Communication Labelling 75

Express Pharma

JUNE 28, 2023

The value of India’s retail pharmaceutical market is estimated to touch $59 billion by the fiscal year 2023, which presents a promising opportunity for retail pharmacies to bolster and strengthen their operations. However, a management system can help ensure the security and availability of all medicine stocks, resulting in cost savings.

Online Pharmacies 95

Online Pharmacies Customer Service Data Entry Packaging 95

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. Accurate measurement of these energy shifts enables a detailed analysis of the types of chemical bonds present in the sample. The second wave promises useful innovations for pharmaceuticals.

Labelling 121

Labelling Packaging Drug Development 121

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.

Adverse Reactions 105

Adverse Reactions Dosage Mayo Clinic Medical Schools 105

European Pharmaceutical Review

SEPTEMBER 2, 2022

The call for transparency in the presentation of study sampling methodology should not be limited to RMM effectiveness studies. The sampling strategy must be supported by sound and properly cited sources whose conclusions must be presented as supportive elements in the study documents. Any additional comments?

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Adverse Reactions Documentation Medical Schools Packaging 96

Pharmaceutical Technology

NOVEMBER 7, 2022

As a vertically integrated company, SHL Medical prides itself on being an end-to-end partner, offering in-house capabilities at every stage – from design, development and production to final assembly, labelling and packaging. Palmetto in North Charleston was the last one, and they did a fantastic presentation for us.

Packaging 52

Packaging Labelling 52

PharmaShots

JUNE 1, 2023

We are conducting an open-label, dose-escalation, phase I/II study PDC-LUNG-101 assessing the safety, tolerability, immunogenicity, and the preliminary clinical activity of therapeutic cancer vaccine PDC*lung, associated or not with anti-PD1 treatment in patients with non-small-cell lung cancer (NSCLC).

Immunity 40

Immunity Immunization Vaccines Health and Personal Care Stores 40

FADIC

MARCH 22, 2024

Because antipyretics can also be found in many allergy, cold, cough, and flu products, patients should be advised to always read all medication labels prior to administration to avoid therapeutic duplications or possible medication overdose. Read the labels carefully and select the appropriate medication for your symptoms.

Immunity 100

Immunity Immunization Dosage Packaging 100

GMPSOP

MAY 26, 2023

– Assessment of packaging and labeling components. computer systems): Make a separate preliminary technical assessment prior to presenting it to the change committee. Printed packaging components are subjected to frequent changes which may require changes in the registration dossier. date, dependencies, etc.).

Documentation 52

Documentation Packaging Communication Customer Service 52

GMPSOP

MAY 26, 2023

– Assessment of packaging and labeling components. computer systems): Make a separate preliminary technical assessment prior to presenting it to the change committee. Printed packaging components are subjected to frequent changes depending on the approved changes in the registration dossier.

Documentation 52

Documentation Packaging Communication Customer Service 52

PharmaShots

MARCH 9, 2023

We are esteemed and elated to present a list of the 20 women who have excelled in reaching the summit of excellence, arranged alphabetically Total experience: 16 yrs. Present company and time period: Pfizer (2 yrs.) Present company and time period: Sensium Healthcare (6 yrs. Present company and time period: Pfizer (26 yrs.)

Clinical Pharmacology 40

Clinical Pharmacology Immunization Immunity Pharmaceutical Companies 40

Pharmacy Friday Pearls

MARCH 9, 2022

It is important to note that at present, Anavip ® is only FDA approved for North American rattlesnake envenomations, even though it is expected that it is safe and effective to use for copperhead and water moccasin envenomations as well. Crofab ® [package insert]. Anavip ® [package insert]. in the treatment group vs 7.4

Immunity 40

Immunity Immunization Packaging Labelling 40

RX Note

SEPTEMBER 23, 2023

In MDIs, drug is either dissolved or suspended in liquid propellant(s) together with other excipients, including surfactants, and presented in a pressurized canister fitted with a metering valve. Introduction Metered-dose inhalers (MDIs) were introduced in the mid-1950s and are the most commonly used inhalation drug delivery devices.

Packaging 52

Packaging Labelling 52

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.

Documentation 52

Documentation Method Validation Packaging Data Entry 52

Quality Matters

APRIL 26, 2023

Ingredient and product quality assurance The potential for variation in medical product manufacturing, distribution and regulatory capability across regions and economies can present challenges to ensuring quality and pose threats to patient safety and public health.

Prescription Filling 52

Prescription Filling Generic Medicine Packaging Labelling 52

Pharmaceutical Technology

NOVEMBER 25, 2022

The API present at 20% was formulated for immediate release, whereas the API that comprised 80% of the total was formulated as extended release over 24 hours. These types of scenarios become even more complicated when one of the two drugs must be released before the others. Faster to market.

Dosage 52

Dosage Pharmaceutical Companies Pharmaceutical Companies Packaging 52

Birth Control Pharmacist

SEPTEMBER 20, 2021

Breakthrough bleeding was present in 33.8% 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]. of the E4/DRSP group group versus 47.8% of the E2 V/DNG group.

Adverse Reactions 52

Adverse Reactions Packaging Labelling Diabetes 52