FDA Law Blog: Biosimilars

JULY 10, 2023

FDA communicates via a Substantive Interaction to inform the submitter either that FDA will proceed with Interactive Review or that the 510(k) will be placed on hold until FDA receives a complete response to an Additional Information request. By Day 15 FDA conducts Acceptance Review. By Day 60 FDA conducts Substantive Review.

Documentation 75

Documentation Packaging Communication Labelling 75

GMPSOP

MAY 26, 2023

Change control management is a systematic process by which a change to facilities, products, systems, or processes is proposed, assessed by a committee (technical and operational impacts), approved, implement, reviewed for effectiveness, and communicated to a larger audience. – Assessment of packaging and labeling components.

Documentation 52

Documentation Packaging Communication Customer Service 52

GMPSOP

MAY 26, 2023

Change control management is a systematic process by which a change to facilities, products, systems, or processes is proposed, assessed by a committee (technical and operational impacts), approved, implement, reviewed effectiveness, and communicated to a larger audience. – Assessment of packaging and labeling components.

Documentation 52

Documentation Packaging Communication Customer Service 52

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

Table 1: Virtual Technology Platform: Pros and Cons Pros AR VR MR XR Metaverse Enhanced user experience/interaction √ √ Immersive and Engaging Experience √ √ Increased Collaboration and Communication √ √ √ Social interaction √ √ √ √ √ Used in training and simulation √ √ √ √ Enhanced Connectivity √ Creative Expression √ Cons Cybersickness AR VR MR XR (..)

Medication Dispensing 78

Medication Dispensing Medication Labelling Packaging Compounding 78

European Pharmaceutical Review

OCTOBER 5, 2022

For most consumers, product packaging represents their first impression of a brand and its sustainability credentials. But how is this push shaping the pharma packaging market and what are the key changes we can expect to see? For many, aesthetic appeal and user experience top the list of priorities when it comes to packaging design.

Packaging 82

Packaging Dosage Labelling Communication 82

European Pharmaceutical Review

NOVEMBER 24, 2022

One area in which the problem can be tackled effectively is product packaging. With predictions that the global market for anticounterfeiting packaging is set to reach almost $250 billion by 2026, growth in authentication and anti-tamper devices such as holograms appear to have a healthy future.”

Packaging 95

Packaging Labelling Documentation Dosage 95

FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

The guidance describes elements that would be required of VCS bodies for recognition of standards they adopt: openness (with meaningful opportunities to participate), balance (broad range of stakeholders), due process, an appeals process, and consensus.

Packaging 59

Packaging Documentation Labelling Communication 59

GMPSOP

NOVEMBER 6, 2022

After the preparation secondary reference standards are tested for potency, labelled, dated and stored, handled and used in testing so as not prejudice quality. d) When the reference standard is first opened, an “opened date” must be written on the label of the vial. Where relevant, a date for re-standardization should be recorded.

Labelling 52

Labelling Documentation Packaging Communication 52

GMPSOP

AUGUST 23, 2022

Is this system used in the creation or verification of product labelling (inserts, outserts, cartons or packaging)? process change, product recall, labelling change, adverse event/safety reporting)? All written and updated by GMP experts. Checkout sample preview s. Access to exclusive content for an affordable fee.

Documentation 52

Documentation Communication Pharmaceutical Manufacturing Labelling 52

European Pharmaceutical Review

JANUARY 23, 2023

MSSG stresses the importance of transparency in relation to shortages and highlights the need for all stakeholders to communicate in an objective and responsible way to avoid any undue public concern. In addition, MSSG supports temporary national measures such as unit dose dispensing and compounding.

Packaging 92

Packaging Compounding Labelling Communication 92

GMPSOP

MARCH 17, 2023

Immediately communicate the incident to stakeholders and initiate an internal laboratory investigation. In a packaging line, a printer was used to imprint manufacturing and expiry dates on a batch of empty cartons which will be used to fill tablet strips. No, this will be a violation of good laboratory practice.

Documentation 52

Documentation Packaging Process Improvement Pharmaceutical Manufacturing 52

RX Note

OCTOBER 5, 2023

Such events may be related to professional practice and healthcare products, procedures and systems, including prescribing; order communication; product labelling, packaging and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.

Health and Personal Care Stores 52

Health and Personal Care Stores Labelling Packaging Compounding 52

RX Note

DECEMBER 16, 2023

This incident highlights the potential dangers of unconventional medical abbreviations in prescription communication. I did not identify any errors on medication label and the quantity prepared. Also, similar packaging design across medication strengths can lead to inadvertent selection errors, potentially impacting patient safety.

Labelling 52

Labelling Dosage Medication Labelling Packaging 52

GMPSOP

JULY 14, 2023

In other areas, such as in secondary packaging or in material storage areas, the product isn’t exposed to the environment, so there is a lower risk of contamination. They should never be topped up, used, or stored without labels and expiry dates. via visual inspection or by communication with the responsible personnel).

Documentation 52

Documentation Labelling Pharmaceutical Manufacturing Packaging 52

GMPSOP

JULY 23, 2023

Add the objective of the installation qualification protocol Write the objective of the protocol defining the installation qualification (IQ) and operational qualification (OQ) requirements and acceptance criteria for the equipment with location i.e., packaging or manufacturing, and the facility.

Documentation 52

Documentation Method Validation Packaging Labelling 52

Putting Patients First Blog

JULY 10, 2023

Communication with the FDA We appreciate that the FDA has emphasized the need for sponsors and patients to interact with the Agency early and often when utilizing these guidances. This clear communication will help achieve a smooth transition and effective application of the four guidances.

Communication 40

Communication Drug Development Packaging Labelling 40

GMPSOP

MARCH 4, 2023

According to FDA Guidance for Industry – Q9 Quality Risk Management , “Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of the drug product across the product lifecycle. How to communicate risk? Packaging and labelling operations v.

Documentation 52

Documentation Communication Method Validation Packaging 52

GMPSOP

JULY 31, 2023

– High-Speed Tablet/Capsule Counting Machines (Critical for accurate counting and packaging of tablets and capsules). 90% to 110% of the label claim). Integration Testing: Acceptance Criteria: The PLC software should be integrated and tested with other control systems and equipment to verify proper communication and coordination.

Documentation 52

Documentation Dosage Labelling Data Entry 52

The Thyroid Pharmacist

OCTOBER 27, 2023

Follow package instructions. These signals create communication and function within nerves and muscles, as the electrolytes move in or out of cells. Follow package directions for each supplement. Precautions Do not take more than the recommended dose on the label. The herb itself can be poisonous if ingested.

Health and Personal Care Stores 66

Health and Personal Care Stores Immunity Immunization Compounding 66

RX Note

FEBRUARY 23, 2023

Terazosin - Off-label use in ureteral stone(s) expulsion Topical Corticosteroids - Apply thinly on the skin using fingertip unit. Statins - Not all statins need to be taken at night. Figures - Elemental iron and calcium content? Human Touch - Why Artificial Intelligence cannot replace us still?

HIV Treatment and Prevention Agents 75

HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 75

Pharmaceutical Technology

JUNE 19, 2023

Issues with regulatory requirements and documentation can also cause significant delays, while any inaccuracies in translations on labelling can mean that dosage and storage information is not correctly understood or followed. And accurate labelling and translation are critical for this sector.

Labelling 52

Labelling Packaging Documentation Dosage 52

Pharmaceutical Technology

APRIL 26, 2023

Packaging plays a critical part in the pharmaceuticals and medical devices industries and is developed with its own set of security standards for the safety of consumers. The role of primary packaging has extended beyond the primary objectives of sterility, physical and chemical protection, and security.

Packaging 52

Packaging Documentation Communication Labelling 52

Pharmaceutical Technology

MARCH 21, 2023

Based on the individual contract, these CMOs manufacture small molecules or biological active pharmaceutical ingredients (APIs), as well as packaging material, and are charged with other related functions. Sharp Packaging Services is producing the solid dose of the drug and packaging it.

Packaging 59

Packaging Vaccines Labelling Diabetes 59

Pharmaceutical Technology

JANUARY 15, 2023

While Catalent Inc and PCI Pharma Services are in charge of the solid dose and packaging of Lupkynis, Lonza is manufacturing the small molecule API. In the same month, the EMA expanded the label of Gilead Sciences’ Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) to include its use for virologically suppressed HIV-positive children.

Labelling 52

Labelling Packaging Diabetes Communication 52

Pharmaceutical Technology

JUNE 20, 2023

It plans to work with the FDA to plan new analyses and further develop a new application package. Data presented was drawn from the first 100 patients enrolled in F2G’s Phase IIb, single-arm, open-label trial (NCT03583164). Please check your email to download the Report.

Packaging 52

Packaging Labelling Communication 52

Pharmaceutical Technology

FEBRUARY 27, 2023

Contract manufacturing organizations (CMOs) not only produce the active pharmaceutical ingredient (API) at the heart of a therapy, but are also responsible for the sterile manufacturing and packaging of liquid and inhalational drug constituents and packaging, depending on the needs of the particular therapy.

Packaging 52

Packaging Chemotherapy Labelling Communication 52