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 2022 | financial year 2021 | Change |
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 2022 | financial year 2021 | Change |
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 2022 | financial year 2021 | Change |
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 Fees | financial year 2022 | financial year 2021 | Change |
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
