Eur monograph 0064. The batches were commercial batches manufactured to the production methods and specification described in the MA. The potencies of the two reference batches (9097 and 9861) are higher than the PEI reference serum and the reference vaccine batch 8500. The MAH followed the correct SOP for replacement at the time the replacements were made.

Weight or number of sublots

Batch certification

This information shall include all available details, in particular the data necessary for the identification of the non compliant instrument, the origin of the instrument, the nature of the non compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator.

Analytical profile of batches

I've made some lots...

consignments that are split into smaller consignments or that are mixed with other consignments

It is strongly recommended that every time you receive a dose of IntronA the name and batch number of the product are recorded in order to maintain a record of the batches used.

SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR o

Prior involvement of candidates or tenderers

Sernam for all the lots

TCS for all the lots

The Manufacturer responsible for batch release is

The manufacturer responsible for batch release is

It is strongly recommended that every time you receive a dose of IntronA the name and batch number of the product are recorded in order to maintain a record of the batches used.

It is strongly recommended that every time you receive a dose of Viraferon the name and batch number of the product are recorded in order to maintain a record of the batches used. i dic

Lots

MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE

batch consistency of vaccines

RESPONSIBLE

It is strongly recommended that every time you receive a dose of Viraferon the name and batch number of the product are recorded in order to maintain a record of the batches used. i dic

Adulterated consignments

MEDICINAL PRODUCTS GMP INSPECTION AND BATCH CERTIFICATION

Ordinance of the Federal Ministry of Justice and Police of 15 August 1986 on weights (RO 1986 2022), as last amended on 7 December 2012 (RO 2012 7183)

If batch follow up is required in the particular safeguard provisions, the batch designation previously used for the batch in an inventory change report or in a previous physical inventory listing must be used.

MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE

Manufacturer Responsible for Batch Release

80 Manufacturer Responsible for Batch Release

21 Manufacturer responsible for batch release

To be completed nationally This section is not to be harmonised

The manufacturer responsible for batch release

Manufacturer for the batch release

Manufacturer responsible for Batch Release

Manufacturer for batch release

Manufacturer responsible for the batch release

Manufacturer for the batch release

Manufacturer for the batch release

Manufacturers for the batch release

Manufacturer responsible for batch release

Manufacturer for the Batch Release

Preparation

Article 47 Negotiated procedure with prior call for competition

Extraneous agents testing of batches of finished product, if required.

Extraneous agents testing of batches of finished product, if required.

Aggregate samples thus obtained shall be considered as representative for the lots or sublots from which they are taken.