National Association of Boards of Pharmacy

DECEMBER 4, 2024

After years of development, revised compounding standards from United States Pharmacopeia (USP) became effective on November 1, 2023. USP Chapter <795> focuses on nonsterile compounding, with updates aimed at improving quality, safety, and consistency.

Compounding Pharmacies 49

Compounding Pharmacies Compounding Documentation Sterile Compounds 49

GMPSOP

APRIL 3, 2023

In other word, you need GMP documentation specially developed and used for your laboratory to guide you through everything you do in the lab. Depending on the objective of the lab, the need for GMP documentation will change for the laboratory. The significance of well-designed GMP documentations is immense.

Documentation 52

Documentation Method Validation Compounding Data Entry 52

PharmaTech

DECEMBER 11, 2023

The agency released two guidance documents on the interim policy on compounding using bulk drug substances for both outsourcing and non-outsourcing facilities.

Compounding 40

Compounding Documentation 40

Pharmaceutical Technology

SEPTEMBER 8, 2022

Pharmaceutical compounding is a method of preparing personalised medications for patients by mixing the individual ingredients in the exact strength and dosage form required by the patient. Discover the top pharmaceutical compounding companies in contract marketing. Benefits of pharmaceutical compounding. Excipients.

Compounding 40

Compounding Compounding Pharmacies Sterile Compounds Dosage 40

European Pharmaceutical Review

JULY 24, 2023

A paper published in Pharmaceutics has proposed how a personalised preparation quality assurance programme can achieve this when these products are developed in compounding laboratories. It requests that compounding laboratories adhering to the programme send samples of it. These are documented and their root cause is sought.

Compounding 93

Compounding Documentation Drug Development 93

European Pharmaceutical Review

JANUARY 25, 2024

This document is revised from a version published in October 2023. Firstly, leachables can compromise a products quality and therapeutic effect, by potentially interacting with the formulated drug product, the document reported. Moreover, manufacturers should document information about their safety thresholds, the guidance stated.

Documentation 98

Documentation Method Validation Packaging Labelling 98

FDA Law Blog: Biosimilars

FEBRUARY 2, 2025

This also includes additional requirements for pharmacies that engage in sterile and complex nonsterile compounding. Specifically, the change of ownership/location documents are quite a bit different and include some new and helpful information to assist applicants wading through the very confusing and cumbersome licensing process.

Packaging 59

Packaging Documentation Compounding 59

Pharma Pathway

DECEMBER 5, 2022

Production: Hands on experience in Vial, Ampoule, Aseptic Area Filling/ Vial Sealing/ Line Chemist/ Compounding/ Autoclave operators. Mandatory Documents: 10th, 12th, UG, PG marks memo, Last three months’ Salary slips, Latest Increment Letter/CTC letter, Last three months Bank Statement. Sterile injectable experience is mandatory.

Documentation 85

Documentation Compounding 85

epicur

DECEMBER 19, 2022

The FDA recently finalized regulatory guidance for compounded animal medications from bulk drug substances for use in non-food-producing animals, impacting the way compounded drugs can be used, documented, ordered, and prescribed. Bulk drug substances are the raw active ingredients most compounded medications are made from.

Compounding 52

Compounding Compounding Pharmacies Documentation Dosage 52

Pharma Pathway

JANUARY 30, 2023

Hands on experience in Vial, Ampoule, Aseptic Area Filling/ Vial Washing/ Vial Sealing/ Line Chemist/ Compounding/ Autoclave operators Sterile injectable experience is mandatory. Phase III, TSIIC. Phase III, TSIIC. Pashamylaram.

Compounding 67

Compounding Documentation 67

European Pharmaceutical Review

NOVEMBER 28, 2024

Undefined terms like “undue delay” and “disproportionate effort” add layers of uncertainty, which are further compounded by the fact that enforcement will rely on varying capacities and interpretations, as the EU relies on 27 independent data protection authorities 3 to enforce regulations.

Documentation 105

Documentation Compounding 105

Pharma Pathway

JANUARY 3, 2023

Production: Hands on experience in Vial, Ampoule, Aseptic Area Filling/ Vial Sealing/ Line Chemist/ Compounding/ Autoclave operators. Hands on experience in Vial, Ampoule, Aseptic Area Filling/ Vial Washing/ Vial Sealing/ Line Chemist/ Compounding/ Autoclave operators. Sterile injectable experience is mandatory. Phase III, TSIIC.

Compounding 62

Compounding Documentation 62

FDA Law Blog: Biosimilars

SEPTEMBER 11, 2024

FDA says that highly potent compounds – again, as defined in ICH M7(R2) – pose risks below that limit. We note that the other FDA guidance document on nitrosamines addresses NDSRIs. Using the guidelines found in the ICH M7(R2) , FDA set an AI threshold of 1.5

Documentation 105

Documentation Compounding 105

European Pharmaceutical Review

JULY 13, 2023

While this is essential in the interrogation of novel compounds for which we know very little about their efficacy and safety, it is also true that some biomedical research is highly wasteful. 3 Moreover, some studies have suggested that co-administration of these compounds can modulate the effects of one another at a receptor level.

Compounding 98

Compounding Drug Development Clinical Pharmacology Documentation 98

Pharma Pathway

FEBRUARY 26, 2023

Hands on experience in Vial, Ampoule, Aseptic Area Filling/ Vial Washing/ Vial Sealing/ Line Chemist/ Compounding/ Autoclave operators Sterile injectable experience is mandatory. Phase III, TSIIC. Phase III, TSIIC. Pashamylaram.

Compounding 52

Compounding Documentation 52

Pharmacy Joe

OCTOBER 25, 2023

Subscribe on iTunes , Android , or Stitcher If you navigate to the page on the website for the Institute for Safe Medication Practices that once hosted the document titled “Oral Dosage Forms That Should Not Be Crushed” you will instead find a notice that the list has been removed from the ISMP website.

Dosage 111

Dosage Inpatient Packaging Documentation 111

pharmaphorum

OCTOBER 21, 2021

It can be given to patients who have the most debilitating form AHP, with four or more severe attacks a year, according to a final appraisal document from NICE, which reverses an earlier position that the drug should not be made available by the NHS. It was approved by the European Medicines Agency (EMA) last year.

Documentation 98

Documentation Compounding Hospitals 98

Pharmaceutical Technology

OCTOBER 31, 2022

On receiving approval, the treatment is expected to replace the requirement to use unapproved repackaged oncologic IV bevacizumab from compounding pharmacies for wet AMD treatment. It is also developing registration documents for approvals in Europe, with submission expected in the fourth quarter of this year.

Labelling 59

Labelling Compounding Pharmacies Compounding Documentation 59

epicur

NOVEMBER 10, 2022

If so, did you document it? Answering no to either of those documentation questions could mean your practice is at risk. 5 Reminders for Properly Documenting a Spilled or Broken Bottle of a Controlled Substance A spill or breakage does not constitute a loss because the registrant can account for the controlled substance.

Controlled Substances 52

Controlled Substances Documentation Compounding Pharmacies Compounding 52

GMPSOP

MAY 31, 2024

A validation master plan (VMP) is a strategic document that identifies the elements to validate, the approach to each element, organizational responsibilities, and a strategy for maintaining validation documentation. – General guidance for validation document format. Additional documents included each month.

Documentation 59

Documentation Method Validation Pharmaceutical Companies Pharmaceutical Companies 59

epicur

AUGUST 8, 2023

Implementation of GFI #256 Earlier this year, the FDA finalized regulatory guidance for compounded medications, known as GFI #256. If GFI is affecting your practice’s ability to get compounded medications for office use, partnering with a trusted 503B outsourcing facility can help you eliminate risks of limited ordering.

Compounding 52

Compounding Documentation Compounding Pharmacies Packaging 52

Pharmaceutical Technology

SEPTEMBER 15, 2022

Bristol Myers Squibb (BMS) documented a 9.1% All top 20 biopharmaceutical companies recorded positive compound annual growth rates (CAGRs) in revenue during 2017–21, with BioNTech (319%) and Moderna (208%) leading thanks to their Covid-19 vaccine franchises.

Vaccines 108

Vaccines Drug Pricing Biosimilars Documentation 108

pharmaphorum

JUNE 23, 2022

The suit – filed in a Massachusetts district court – claims that Paxlovid (nirmatrelvir and ritonavir) infringes its 11,358,953 patent which covers “compounds and pharmaceutically acceptable salts which inhibit coronavirus replication activity, and methods of treating a coronavirus infection” and was awarded earlier this month.

Compounding 52

Compounding Documentation 52

Eye on FDA

AUGUST 2, 2022

There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceutical companies; one is through the issuance of guidance documents, the other is through enforcement. But when it comes to enforcement things have changed greatly over the years.

Communication 88

Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 88

Pharmaceutical Technology

SEPTEMBER 7, 2022

Compounding services. The document contains detailed information on the suppliers and their product offerings, alongside contact details to aid your purchasing or hiring decision. The list includes companies offering various products and services, including but not limited to: · Over-the-counter drugs. Speciality care.

Online Pharmacies 45

Online Pharmacies Documentation Compounding Diabetes 45

GMPSOP

JUNE 9, 2024

Additional documents included each month. employee assay qualification) must be documented in an SOP for each assay the lab performs with pre-determined acceptance criteria. employee assay qualification) must be documented in an SOP for each assay the lab performs with pre-determined acceptance criteria. gown qualification).

Method Validation 52

Method Validation Documentation Health and Personal Care Stores Labelling 52

RX Note

NOVEMBER 19, 2023

In the rotation, you will be Trained in aseptic techniques to compound sterile preparations inside laminar flow cabinet Trained to ensure the appropriateness of the PN solution supplied in terms of its composition. ASPEN published new guidelines for parenteral nutrition in preterm infants in 2023.

Hospitals 52

Hospitals Documentation Compounding 52

GMPSOP

FEBRUARY 10, 2024

Additional documents are included each month. – Training requirements for each role are identified, documented, approved and kept current. This includes ensuring that references to the version of a given document align with the corresponding entry on the Controlled Document Index. Check out sample preview s.

Health and Personal Care Stores 52

Health and Personal Care Stores Documentation Packaging Compounding 52

RX Note

JUNE 5, 2023

Workplace activity involves how healthcare workers use and handle the drug in the workplace - such as opening shipments, compounding, administering or cleaning up after use or spills. Oral hazardous drugs No crushing or compounding may be done in an unprotected environment. Consider having spill-response exercises or drills.

Compounding 52

Compounding Packaging Hospitals Chemotherapy 52

Pharma in Brief

FEBRUARY 3, 2021

The 202 Patent: compound and use claims valid and infringed. At the time it was published, the claims in the 202 Patent application included a large number of compounds. The Defendants argued that the disclosure did not support the broader scope of compounds in the published application. Construction. Anticipation.

Compounding 52

Compounding Documentation 52

Pharmaceutical Technology

DECEMBER 15, 2022

From alcohols to quaternary ammonium compounds, each type of agent has a unique mode of action, with varying degrees of efficacy. In addition, several pieces of documentation will be required to support the API qualification, e.g. pharmacopeial compliance. There are many other aspects to take into consideration.

Documentation 52

Documentation Compounding Communication Pharmaceutical Companies 52

GMPSOP

FEBRUARY 15, 2024

Approval of cleaning compounds The quality assurance manager is responsible for approving cleaning compounds that are safe to use during housekeeping cleaning activities. Additional documents included each month. Labelling and documentation Clearly label all containers, equipment, and production areas.

Documentation 52

Documentation Labelling Compounding Packaging 52

Syner-G

SEPTEMBER 15, 2023

Structure-based drug design has evolved, facilitating the exploration of novel chemical probes and lead compound potency, and molecular docking utilizes target structures to predict interactions and offers simplicity and speed. This shift from a linear to a network approach enhances the potential for one drug to target multiple sites.

Drug Development 59

Drug Development Documentation Process Improvement Compounding 59

GMPSOP

OCTOBER 28, 2023

The analyst should ensure that the supervisor is notified as soon as an OOS event occurs, the sample is retained, and a documented investigation is commenced. – Document control records management and archiving systems. Additional documents included each month. You must document all sampling procedures and plans in use.

Documentation 52

Documentation Method Validation Packaging Data Entry 52

European Pharmaceutical Review

MARCH 12, 2024

Good documentation practices. Following good documentation practices (GDP) throughout all stages of data generation, collection, analysis and reporting is vital. This involves keeping accurate and up-to-date records, documenting any deviations and corrective actions, and providing sufficient training to employees on GDP standards.

Documentation 98

Documentation Data Entry Communication Compounding 98

RX Note

MARCH 28, 2024

Under Regulation 16 , all registers, records, book, prescriptions, signed orders and other documents shall be kept for a period of 2 years from the data on which the last entry is made.

Documentation 52

Documentation Drug Storage Compounding 52

National Association of Boards of Pharmacy

JULY 31, 2024

For example, Form 483 Notifications or Warning Letters that you or your affiliates have received from the Food and Drug Administration (FDA) relating to pharmacy compounding must be resolved. These include all licenses, previous disciplinary actions, and other supporting documents. Model notices are posted on HHS’ website.

HIPAA 45

HIPAA Documentation Compounding 45