Pharma GMP News of the Week: 15-August-2021

Period: August 8, 2021 to August 14, 2021

A new post, “Transfer of analytical methods” has been published on the MHRA Inspectorate blog – Guidance for manufacturers and contract testing laboratories on the process of transferring a method for outsourcing of testing.

Date of publishing: August 13, 2021

Technical transfer of analytical methods, or analytical method transfer (AMT) is a GMP requirement for those involved in contract manufacturing and testing. Finally, here are some common findings around AMT:

Some common findings around AMT are:

  • Equipment was not qualified for the range used in the transferred method
  • The impact of differences in equipment was not included in the gap analysis – such as different makes and models of high performance liquid chromatography (HPLC) equipment used at transferring and receiving sites
  • The receiving laboratory did not follow the transfer protocol
  • The method references internal documents from the transferring laboratory which were not available at the receiving laboratory
  • AMT was performed as a single test, on one batch of product: examples being, one single agar plate for a microbiology assay, one dissolution test, one assay test without appropriate justification
  • A single strength was used to transfer methods used for multiple strengths

Source: https://mhrainspectorate.blog.gov.uk/2021/08/13/transfer-of-analytical-methods/

US Food and Drug Administration (FDA) has published: Following user fees that will be collected in financial year 2022 from manufacturers of pharmaceuticals, generic drugs, biosimilars, medical devices, and outsourcing facilities.

Prescription Drug User Fee Act (PDUFA VI)financial year 2022financial year 2021Change
Applications:   
     Requiring clinical data$3,117,218$2,875,842$241,376
     Not requiring clinical data$1,558,609$1,437,921$120,688
Program fee$369,413$336,432$32,981

Reference: https://public-inspection.federalregister.gov/2021-17505.pdf

Generic Drug User Fee Amendments (GDUFA II)financial year 2022financial year 2021Change
Applications:   
     Abbreviated new drug application (ANDA)$225,712$196,868$28,844
     Drug master file (DMF)$74,952$69,921$5,031
Facilities:   
     Active pharmaceutical ingredient (API) – Domestic$42,557$41,671$886
     API – Foreign$57,557$56,671$886
     Finished dosage form (FDF) – Domestic$195,012$184,022$10,990
     FDF – Foreign$210,012$199,022$10,990
     Contract manufacturing organization (CMO) – Domestic$65,004$61,341$3,663
     CMO – Foreign$80,004$76,341$3,663
GDUFA program:   
     Large size operation generic drug applicant$1,536,856$1,542,993-$6,137
     Medium size operation generic drug applicant$614,742$617,197-$2,455
     Small business operation generic drug applicant$153,686$154,299-$613

Reference: https://www.federalregister.gov/documents/2021/07/28/2021-16039/generic-drug-user-fee-rates-for-fiscal-year-2022

Biosimilar User Fee Amendments (BSUFA II)financial year 2022financial year 2021Change
Initial biological product development (BPD)$57,184$102,494-$45,310
Annual BPD$57,184$102,494-$45,310
Reactivation$114,368$204,988-$90,620
Applications:   
     Requiring clinical data$1,746,745$1,746,745$0
     Not requiring clinical data$873,373$873,373$0
     Program$304,162$304,162$0

Reference: https://www.federalregister.gov/documents/2021/07/28/2021-16084/biosimilar-user-fee-rates-for-fiscal-year-2022

Medical Device User Fee Amendments (MDUFA IV)financial year 2022 (small business fee)financial year 2021 (small business fee)Change
Premarket application (a PMA submitted under section 515(c)(1) of the FD&C Act (21 U.S.C. 360e(c)(1)), a PDP submitted under section 515(f) of the FD&C Act (21 U.S.C. 360e(f), or a BLA submitted under section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262))$374,858
($93,714)                               
$365,657
($91,414)
$9,201
($2,300)
Premarket report (submitted under section 515(c)(2) of the FD&C Act)$374,858
($93,714)
$365,657
($91,414)
$9,201
($2,300)
Efficacy supplement (to an approved BLA under section 351 of the PHS Act)$374,858
($93,714)
$365,657
($91,414)
$9,201
($2,300)
Panel-track supplement$281,143
($70,286)
$274,243
($68,561)
$6,900
($1,725)
De novo classification request$112,457
($28,114)
$109,697
($27,424)
$2,760
($690)
180-day supplement$56,229
($14,057)
$54,849
($13,712)
$1,380
($345)
Real-time supplement$26,240
($6,560)
$25,596
($6,399)
$644
($161)
510(k) premarket notification submission$12,745
($3,186)
$12,432
($3,108)
$313
($78)
30-day notice$5,998
($2,999)
$5,851
($2,926)
$147
($73)
513(g) request for classification information$5,061
($2,530)
$4,936
($2,468)
$125
($62)
Annual fee type:   
     Annual fee for periodic reporting on a Class III device$13,120
($3,280)
$12,798
($3,200)
$322
($80)
     Annual establishment registration fee$5,672
($5,672)
$5,546
($5,546)
$126
($126)

Reference: https://www.federalregister.gov/documents/2021/08/02/2021-16408/medical-device-user-fee-rates-for-fiscal-year-2022

Outsourcing Facility Feesfinancial year 2022financial year 2021Change
Qualified small business establishment fee$5,824$5,695$129
Non-small business establishment fee$18,999$18,837$162
Re-inspection fee$17,472$17,085$387

Reference: https://www.federalregister.gov/documents/2021/07/28/2021-16057/outsourcing-facility-fee-rates-for-fiscal-year-2022

image 13

Check on Amazon

Scroll to Top