• Quality maintained during distribution: the responsibility for maintenance of quality does not end at the factory gate. It is important that throughout the distribution chain, appropriate controls and storage conditions are maintained. This is reasonably easy when the manufacturer controls the distribution channel. However, even when the products are distributed by other entities (such as wholesalers), there is still a responsibility to ensure that they are aware of and understand the importance of all such requirements.

• Recall system: whilst no company wants to have to deal with a recall situation, it is necessary for all companies to be prepared for this eventuality. A procedure must be in place, which has been tested in a ‘dry run’ to ensure that it will operate effectively.

• Complaints system: all complaints must be investigated to determine whether they are justified or not. If they are justified, it is necessary to determine whether this is a one- off occurrence or part of a trend. Actions must be put in place to rectify any immediate problems and prevent any recurrence.

Batch packaging records
The batch packaging record is required for every batch or part batch that is packaged. It is developed from the relevant part of the packaging instructions and, once again, its review is an important part of the batch release process. Depending on company practice and the design of the document, it may be specific to a particular batch size or may be used for a variety.
Comments made previously regarding area clearance checks also apply here. Use of a checklist for these checks is very helpful. Looking under tables and checking for extra labels or primary containers are very important.
The information required for the completed batch packaging record will once again consist of a combination of pre-printed material and data that are added by the operators during the process.
If returns to the stores are permitted for printed packaging materials, they should first be checked to make sure that they have not been batch coded. A QC signature is required as part of this process, either on leaving the packing hall or being received in the stores.
If excess materials are destroyed, there must be a record of the quantities on the batch documentation. There should also be a procedure covering destruction, including methods and responsibilities.
Reconciliation is of vital importance, since it helps to confirm that the batch has been processed correctly. Any significant variation in materials should be taken as an indication that there could be a problem and must be investigated before the batch is released.

Pineal Gland

Synthesizes melatonin, which – because of its position in the third ventricle – is secreted directly into the cerebrospinal fluid (CSF), from where it finally ends up in the blood. Melatonin affects reproductive development and daily physiology.

MCQ No. 1973 | Pharmaceutical Chemistry

The protein synthesis inhibitors act by disrupting the bacterial 70S ribosomal mRNA complex that is responsible for bacterial protein synthesis. Since eukaryotes utilize a different ribosomal complex (80S), these drugs do not interfere with human cellular protein synthesis. The bacterial 70S ribosomal complex is composed of two subunits (30S and 50S), and the protein synthesis inhibitors act at one of these subunits.

The nucleoside (NRTIs), nucleotide, and nonnucleoside (NNRTIs) reverse transcriptase inhibitors (RT inhibitors) all inhibit the formation of viral DNA from RNA by reverse transcriptase.

The protease inhibitors interfere with processing of the viral protein, thus preventing formation of new viral particles.

Enfuvirtide blocks the fusion of the viral particle to the target cell, while maraviroc inhibits entry of the viral particles into cells.

Raltegravir is the first available integrase inhibitor.

Therapy for HIV is either based on inhibition of RT using one NNRTI + two NRTIs or based on use of a protease inhibitor using one or two PIs + two NRTIs.

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