Friday, September 30, 2016

Management Reviews

To bring coherence in organisational functioning as also to determine operational performance, the top management of the company reviews the system performance regularly discussing all relevant issues so as to achieve performance improvement. A system of internal communication has also been established.

Monday, September 19, 2016



To describe the procedure for reprocessing of intermediate or API, which does not confirm to the standards or specifications.

Tuesday, September 13, 2016

Common terms used in API and Food Industries

In this article terms are defined which are commonly used in the API and food industries:

1. Deviation: 

Departure from an approved instructions or established standards.
[Instructions or standards are commonly specified in Standard operating procedure and Technical Instruction. Also Deviation is related to the systems not the product. ]

Wednesday, September 7, 2016

SOP on Rework

1.0            OBJECTIVE

1.1  To define the standard operating procedure for the rework of Intermediate/API.

2.0            RESPONSIBILITY

2.1            Head Quality Control

2.2            Head Quality Assurance

2.3            Head Production

3.0            PROCEDURE
3.1            Definition of rework
3.1.1     Subjecting an intermediate or API that does not conform to  standard or specifications to one or more processing steps that are different from the established manufacturing process to obtain the acceptable quality intermediate or API.

3.2     Whenever a product is found out of specification or non conform, depending upon the nature of failure, a discussion is held between QA, Production, QC and R&D to determine the following:
 3.2.1       Reason for failure and investigation there off.
 3.2.2    Whether the batch is to be reprocessed or reworked to bring it up to the specification.
3.2.3 Whether stability study will be required?
3.2.4 Whether any specific controls to be exercised during rework in case it is to be reworked.

3.3       Based on the outcome of this discussion if rework is recommended then following procedure is adopted.
3.4    Based on the area of non-compliance, production Incharge determines reworking program or method of non conforming batch/material in consultation with quality assurance, quality control and if needed be with R & D.
3.5            It is also determined whether the situation is likely to occur again.
3.6         If it is found to be one –off situation proper technical study is undertaken for the efficacy of the rework protocol in achieving the rework objectives.
3.7          This protocol is adopted only if its technical soundness is fully established.
3.8     If however it is found that the non conforming situation is such that it may occur again, in that case the rework protocol is suitably validated before adoption.
3.9       The rework protocol is documented along with any control measure and records that are to be made to ensure compliance to the protocol.
3.10       A draft manufacturing record shall be prepared by production on the basis of recommendation of QA, QC and R&D.
3.11       Batch number shall be assigned as per Batch numbering SOP
3.12       All reworked batches shall be suitably identified so as to make it explicitly clear about their status as a reworked batch.
3.13  After the batch is reworked, the batch is analysed for it compliance with specifications.
3.14    A final test report is issued to production from QC after compliance of product with specification.
3.15    Comparison of impurity profile of each reworked batch against batches manufactured by the established process to be done.
3.16   Where routinely analytical method are inadequate to characterise the reworked batch, additional method should be used from approved accredited laboratory.
3.17       Adequate documents are prepared and archived with the BMR to describe the reason, steps taken and result.
3.18       The accelerated stability studies of reworked batches will be undertaken if the method used in unique and has not been studied for stability earlier.
3.19       The reworked batches may be released for commercial purposes if the quality of such batches is similar to the normal production batches.

4.0            ABBREVIATION
 4.1            NIL

5.0            ANNEXURES
 5.1            NIL

6.0            REFERENCE
6.1            ICH Q7 14.30,14.31,14.32


Tuesday, September 6, 2016

Difference between Rework and Reprocess

Rework and reprocess are very confusing terms. There has always been an uncertainty which procedure is to be followed. Below is an effort to define both in simple terminology

To understand rework and reprocess the first thing is to make it clear that the material which is supposed to be reworked or reprocessed are always the non-conforming products. It means while assessing the disposition of the nonconforming products it will be analysed whether the product shall be reworked or reprocessed.

Rework and reprocess are both not routinely done.

Rework will be done when the material or drug is not having the desired standards, as a result an extra work is done to bring it back to the set standard. This effort of extra work is different from the established validated manufacturing procedure. This is not always necessary that rework is applicable to each and every industry. Nevertheless every industry must have the procedure for rework and at least the middle management and higher are aware of the concept of "Rework".

On the other hand "reprocess is the repetition of the same predefined process."

Therefore, in order to decide whether the SOP of rework or reprocess is to be followed, the first thing which shall come to mind is that the product is a non conforming product. This shall be brought to the notice of higher management. The NCR committee shall decide the disposition of the material.

During decision of the disposition the committee may decide that the material may again follow the same validated procedure or a procedure which is different from the established procedure.

If the same validated procedure is followed than the material is considered to be reprocessed on the other hand if different procedure is followed than the material is said to be reworked.


Friday, September 2, 2016

Good Trade and distribution practices for pharmaceutical starting material

The responsibility of a pharmaceutical handler is higher than other manufacturers as the quality of the pharmaceutical products may severely affect the health of the patients and sometimes may even cause death. Every manufacturer, distributor and traders shall follow good trade and distribution practices and shall do risk assessment of there procedure and prctices to maintain the original quality of their products.  Also the starting material which is added in the pharmaceutical product shall also be included in the scope of risk assessment

The risk during storage, trade and transports are generally similar to those of manufacturing environment. The risk such as packaging, repackaging, labelling, relabelling, storage, distribution and record keeping practices can lead to a substandard drug.