D-U-N-S & F E I

D-U-N-S  &  F E I

 

Data Universal Numbering System (DUNS)

DUNS number is a unique nine digit identification number, provided by Dun & Bradstreet for each physical business location. DUNS users include the European Commission, the United Nations and the United States government. More than 50 global, industry, and trade associations recognize, recommend, or require DUNS. The DUNS database contains over 100 million entries for businesses throughout the world.

FDA will require Data Universal Numbering System (D-U-N-S) numbers for both the facility or site and the registrant owner of the facility or site if the facility or site is in a different location than the registrant owner location. Each distinct physical location of an entity (e.g., branch, division, and headquarter) would be assigned a different D-U-N-S number.
 

The site-specific D-U-N-S number is a widely recognized business identification tool and serves as a useful resource for FDA in identifying and verifying certain business information submitted by a user. If no D-U-N-S number has been assigned, a business entity may obtain one at no cost directly from Dun & Bradstreet. A new number may be obtained, or an existing number verified, by phone or online. Existing facilities D-U-N-S numbers may also be verified on FDA’s current registration site for drug establishments.

Note: It takes Dun & Bradstreet approximately 30 business days to process a new D-U-N-S number and communicate it via email. A business entity may receive a  D-U-N-S number in approximately 10 business days for an expedited service fee.

Facility Establishment Identifier (FEI)

Facility Establishment Identifier (FEI), a unique identifier designated by FDA to assign, monitor, and track inspections of regulated firms. FDA will assign only one FEI number to separate buildings if they are in close proximity and if the activities conducted in each building are closely related to the same business enterprise, are under the supervision of the same local management, and are capable of being inspected by FDA during a single inspection.

A business entity that has previously obtained an FEI number may verify its FEI number on FDA’s registration site for drug establishments.

What is the recommended time for settle plate exposure in clean rooms for environmental monitoring?

What is the recommended time for settle plate exposure in clean rooms for environmental monitoring?

 

EU GMP annex 1 states that settle plates are required to be exposed for a minimum of 4 hours.

Recommended limits for microbiological monitoring of clean areas during operation:

Recommended limits for microbial contamination (a)
Grade	air sample cfu/m3	settle plates (diameter 90 mm)  cfu/4 hours (b)	Contact plates (diameter 55 mm) cfu/plate	glove print 5 fingers cfu/glove
A	˂ 1	˂ 1	˂ 1	˂ 1
B	10	5	5	5
C	100	50	25	-
D	200	100	50	-

 Notes

(a) These are average values.

(b) Individual settle plates may be exposed for less than 4 hours.

 Reference:

EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use – Annexure - I

EDQM - Sister File Procedure

 

Sister File Procedure

 

The sister file procedure is intended to facilitate the submission of similar dossiers within the Certification procedure, and to allow applicants benefit from a fast-track procedure and harmonised assessments. An applicant who has been granted a certificate of suitability (CEP) may wish to apply for a second CEP for the same substance, either because the specifications of the final substance obtained with an alternative process cannot be covered by the  existing CEP or because the applicant wishes to have separate CEPs for different conditions of preparation or qualities (for example, to cover an alternative manufacturing site or an alternative grade).

This new application can be submitted as a “sister file”,

Note: Sterile and TSE applications are outside the scope of this procedure.

 Conditions:

• The original application should already have been approved by EDQM and the CEP granted
• The manufacturer should be the same for both applications
• Differences described in the new dossier compared to the already granted CEP can be classified and hence treated as a revision.

Documentation:

• New application according to the current procedures
• Reference to the already approved dossier and explanation of differences
• A comparative table of the affected dossier sections for both the approved and the new application
• A subtitle for the CEP of the sister application, in order to differentiate both CEPs.

KF VS LOD

In pharmaceuticals, several methods are employed to determine the water content of a substance/product. Among which Karl Fischer Titration (KF) and Loss on Drying (LOD) are most honored and largely reliable methods.

Loss-on-Drying (Weight Loss)

This method uses the principle of drying a sample of the product and comparing the weight before and after drying. The difference in weight represents the moisture that is in the product. This can be accomplished by using various manner such as drying ovens, infrared balances, and infrared lamps. Whatsoever, the drying conditions are strictly specified. The difference in weight after drying is due to the loss of all evaporated matter, which is taken to represent the moisture content. Repeatability and accuracy of this method solely depend up on the temperature and time controls adopted during testing.

The difficulty is that this technique measures all the moisture lost from the sample, which includes not just water but also any other volatile component already present in the sample (like residual volatile solvents) or created by polymerization or degradation of the sample.

Karl Fischer (KF) Titration

Karl Fischer titration is a very specific determination method which detects and measures only water, including water of crystallization and surface-absorbed water. It is based upon a redox reaction involving water and iodine in the presence of a base, an alcohol, and sulfur dioxide. The water-iodine reaction is dependent upon the presence of water, and therefore the titer of reagent used up in the reaction reflects the amount of water in the sample as there is no other source of water.

The KF reagent contains iodine and when it has completely reacted with the total water, excess iodine appears in the solution, causing a color change as well as an electrometric change which can be detected by a double platinum electrode. KF titration measures total water and is not affected by the presence of residual volatile solvents. It has a wide and sensitive range of determination from a water content of 100% to 1 ppm.

KF	LOD
KF is a method, which measures only the water content (i.e. it's water-specific) in a product sample.	LOD on the other hand, measures the total change in weight of a material as a result of drying. For some products, components such as alcohol or fat evaporate with the water. Therefore, the LOD method measures both the water and volatile impurities such as those mentioned previously
Karl Fischer titration is a chemical method. It involves adding a reagent to the sample to cause a reaction that converts the water in a product to a non-conductive chemical.	Loss on Drying compares the weight of a product before and after it is dried. This difference in weight is taken as the percentage of moisture in the product.

Key Words Loss On Drying Water determination LOD Vs KF Karl Fischer Vs Loss –On Drying –Which Method is Best?