Al Shark Veterinary Products
Al shark Veterinary Products Company is a factory for producing Veterinary Products in different forms (injection, powder, ointment and salt blocks. It was established in 1986 it produces more than 150 different kinds of pharmaceutical forms, cover different of veterinarytreatments.
General idea about the company:
The factory consists of three separated buildings according to (GMP) specifications for pharmaceutical drugs.
1- The management building.
2- Injection section building.
3- Powder, ointment and salt blocks section building.
The buildings have suitable locations designs no pollution can reach to, and protected from entering insects and animals.
The area is suitable for all manufacturing conditions and storing and has good ventilation & lighting according to (GMP) specifications.
The management building: Includes two floors, one for information and other offices, the second for director manager and secretary office and there is a big hall for visitors and for Arab & foreign experts. They are provided with all services.
The most important work conditions in management system is documentation which is an important part of the quality assurance system to (GMP) to have a connect among all activities
The injection building: It's separated from other buildings according to (GMP) conditions, it’s suitable for pharmaceutical manufacturing with sufficient area The building consists of two floors: the first one for raw materials and finished products store as well as the store management with separated door.
The store has a big importance in the pharmaceutical manufacturing scale and the (GMP) conditions are accurate in dealing with the raw materials and testing them , this leads to follow some conditions in order to guarantee our work.
*- All materials are put in a specific place in the store under quarantine as soon as are received after testing them initially and making sure of the safety of the containers and the labels on them and to number them accurately and clearly.
*- Q.C department must be informed with the new raw material arrival in a written way and take a random sample to be analyzed then give the store a permission to manufacture this material and its validity during a limited storing period according to GMP conditions .
*- The finished products subdue to essential series of stages to reach to a good pharmaceutical manufacturing according to (GMP) specifications.
*- The finished products are put in the quarantine till the Q.C allows being in currency.
*- The finished products aren't allowed to be sold till the Q.C department gives a written and authorized permission after a chemical, physical and biological test specified by (GMP) conditions.
*- All previous stages are authorized and registered within special volumes easily used and no fact can be changed except by the supervision and the sign of the store responsible.
*- The rejected products :The good conditions of the pharmaceutical manufacturing obliges us to put them in special quarantine place and prevented to be used in manufacturing and they must be damaged due to a written approval of the Q.C .They sometimes may allow to manufacture them in exceptional cases; if there is no effect on the final quality. Q.C should put specific procedures kept in special records and give them new numbers.
*- The returned products:
- Initially the returned products must be damaged unless they are identical to the measurements which belong to the safety, identity, quality, purity and solidity according to (GMP).
*- The second floor in the injection building:
This floor has two annexes; the first one for production and the second one for Q.C and the laboratory.
- Production section: the conditions of (GMP) obliges us a group of requirements, preparations and procedures whether in the quality of the available supplies, in the nature of work and in all procedures to (GMP)
According to the equipments:
1- The equipments are designed to suit the work and allow to make cleaning and maintenance procedure actively to avoid pollution and to be tested before the use, this must be documented in special record.
2- All used equipments in production do not react with finished materials or affect the drug quality to guarantee any damage not to happen.
3- All used apparatuses in manufacturing are named by their names clearly and should be indicated to the dangerous sites whether mechanic or electrical.
4- Suitable signs are put on all connections in the department denote to the direction and how to be used. Labels must be put on the dangerous electrical, gases and liquids connections.
Manufacturing processes:The conditions of (GMP) clearly limit all manufacturing stages starting from receiving the raw materials and ending to the receiving the finished products to the store ready for selling.
Manufacturing sages: The building is designed in a way not to happen any pollution because the manufacturing stages happen a closed area to prevent the microbial pollution for the drug and there is a room in the section for changing clothes then entering to the aseptic area with special dress, cap and shoes. It's prevented to put watches, jewels and cosmetics.
- It is not allowed to the clean areas except the persons who are authorized, they should enter from the dress room after changing their clothes with special clothes.
- The clean aseptic areas and others must be cleaned according to a written program.
The stages of production followed in manufacturing:
The conditions of (GMP) define the stages of manufacturing accurately whether with the specifications of the used equipments or the section itself.
The stages of production must be authorized with written procedures and labels on the used bottles in all stages.
Production director issues an order to produce a drug to the section chief who prepares a data of the required quantities of the raw materials, packages, labels, and all batch requirements and sends a copy to the store to prepare the materials after checking the weights, and then he sends the materials to the production section.
The batch is prepared in specific areas by the responsible technicians for the batch and registers every step in order not to commit any mistake according to the conditions of (GMP).
After ending the preparation and having a written approval from the Q.C who makes all required analysis for the batch, after giving the approval, the production section starts packaging the batch.
The equipment, the means of the weight, registering and controlling must take care for from time to time, and keep all that in privet records.
The conditions of (GMP) requires putting a program for the packaging processes to guarantee not to mix or change the drugs
Before starting packaging we have to guarantee that there isn't any drug, material and label unnecessary for the current process.
We have to make sure in a written way of the: Name of the product, Lot No:
Mfg date: Exp date: or adding any information on the packages: for example:
For export. Packaging shouldn't start except after a written approval and keep all the process in a privet record.
Q.C department( laboratory ):
The adoption of (GMP) specifications gives a big importance and basic role to the Q.C department in all production stages and can interfere in any stage and make any amendment or even stop the work according to the technical necessities.
Due to this important role for Q.C. department so, it's provided with necessary laboratory apparatus to all stages of analyzing the products whether the raw materials or the finished products from physical, chemical and biological step.
- The most important tasks of Q.C is taking samples and making experiments and document all results and make license for the raw and finished products after the assurance of the quality .Q.C has the right to participate in all decisions belong to the product quality .
- All the procedures made by the Q.C’s workers and technicians are documented and registered, they have the right to enter production areas to take samples if necessary.
- The samples are taken from the raw & finished products within vessels written on the: the material name, lot no. , the date of taking the sample and the signature of who took the sample.
- Tests are done on the samples according to the registered ways and their amendments which are registered in a privet record and adopted in the international references and pharmacopoeia.
- A license to use a raw material or finished product is not given until the director of Q.C allows and the material has been tested and it is identical with standard specifications ( physical ,chemical and biological ) the license must be written , clear , authorized and unmodifiable, a copy is kept in a privet record.
- Q.C keeps the finished product 's samples for one year at least after expired in its envelope and stored according to the recommended conditions .The quantity of the kept samples must be enough to make two extra tests .
The good manufacturing for pharmaceutical drugs gives Q.C a basic role in the study of (Stability) whether from the new or old drugs .We can summarize the tasks of Q.C in our case from the stability side according to (GMP) as follows :
· Studying and evaluating the stability of finished pharmaceutical drugs whether in store conditions by heat or coldness to limited periods according to the constitutional conditions and registering any changes happen to the drug in its privet record and suggesting any amendment in the composition with written and fixed documents.
· Q.C in the factory is responsible for expiry dates according to storage conditions and adopting a statement for the storage conditions written on the package if necessary.
Powder, ointment, and salt blocks section:
One of the most important conditions of the (GMP) is that the areas of manufacturing are separated, not to happen any pollution or overlapping in manufacturing so, powder section is completely separated and far from injection section to prevent pollution and not to overlap the raw with finished products.
The first floor includes the section of salt block producing. The conditions of (GMP) obliges sever conditions on producing salt blocks concerning the place , ventilation , health and precautionary conditions for all workers concerning wearing the special dress and masks to prevent inbreathing dust or some chemical substances during working hours under the supervision of Q.C.
The second floor includes the veterinary producing products / powder , ointment/ taking into consideration the limited conditions in (GMP) starting preparing the Lot from the store of raw materials and getting the approval of Q.C till packaging and receiving the store . All this must be documented.
All workers and technicians are of high awareness and know the importance of their work and aware of the danger of dust risks during working hours and the necessity of taking all necessary procedures according to the estimation of the general management to keep away the toxic states or the health harm from workers .
*- It's notable that the conditions of (GMP) imposes that all managerial and technicians are of high qualifications and experience due to the training they have in the factory and there is also written courses as well as to a healthy program to physical checking up periodically for the workers and technicians.