Medicines and Healthcare products Regulatory Agency
Report No : UK GMP 34063 Insp GMP 34063/627590-0001 NCR
STATEMENT OF NON-COMPLIANCE WITH GMP
Part 1
Issued following an inspection in accordance with :
From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on
13/12/2019
, it is considered that
it does not comply with the Good Manufacturing Practice
requirements referred to in
-
Regulation 331A of The Human Medicines Regulations 2012 (SI 2012/1916)
The Manufacturer :
BIOPLUS LIFE SCIENCES PRIVATE LIMITED
Site address :
BIOPLUS LIFE SCIENCES PRIVATE LIMITED, PHARMED GARDENS, WHITEFIELD ROAD, BANGALORE, IN-560048, INDIA
- The principles and guidelines of Good Manufacturing Practice laid down in Regulation B17 of the Human Medicines Regulations 2012 (as amended)
Part 2
| 1. MANUFACTURING OPERATIONS |
| [ 1.2 ] Non-sterile products |
| [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) |
| [ 1.2.1.1 ] Capsules, hard shell |
| [ 1.2.1.13 ] Tablets |
| [ 1.2.1.17 ] Other non-sterile medicinal productsPowder Sachet |
| [ 1.5 ] Packaging |
| [ 1.5.2 ] Secondary packing |
| [ 1.6 ] Quality control testing |
| [ 1.6.2 ] Microbiological: non-sterility |
| [ 1.6.3 ] Chemical/Physical |
Part 3
Nature of non-compliance:
The Inspection in December 2019 identified failures in the measures to prevent and detect cross-contamination and presented a risk that cross-contamination between products could occur and would not be detected the vendor approval process did not adequately consider the risk of contamination to existing products when introducing new raw materials; the integrity of reported data could not be relied upon; the site had contravened the restrictions on the 2014 GMP certificate.
Recall of batches:
Member states should contact the site to determine the level of risk associated with specific products released to market. MHRA would recommend determining the criticality of the products on the market and to assess if a precautionary recall is appropriate.
Prohibition of supply:
No batches to be supplied to EU markets whilst this statement of non-compliance remains in force.
The Inspection in December 2019 identified failures in the measures to prevent and detect cross-contamination and presented a risk that cross-contamination between products could occur and would not be detected the vendor approval process did not adequately consider the risk of contamination to existing products when introducing new raw materials; the integrity of reported data could not be relied upon; the site had contravened the restrictions on the 2014 GMP certificate.
Recall of batches:
Member states should contact the site to determine the level of risk associated with specific products released to market. MHRA would recommend determining the criticality of the products on the market and to assess if a precautionary recall is appropriate.
Prohibition of supply:
No batches to be supplied to EU markets whilst this statement of non-compliance remains in force.
| 21/02/2020 | Name and signature of the authorised person of the Competent Authority of United Kingdom |
| Confidential | |
| Medicines and Healthcare products Regulatory Agency | |
| Tel : Confidential |
Withdrawal of previous GMP Certificate No: DK H 00111418 (and previous certificate DK H 00049315 and DK H 00011411). Issue of a statement of non-compliance. Due to the nature of the issues identified batches not released to market and included in the scope of the SNC.