Review GMP

Running head: REVIEW GMP
REVIEW GMP
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REVIEW GMP
Answer1
Part a: The objective and the purpose of Good Manufacturing guideline is to provide a
structure by which the manufacturing companies can refer to and also get an appropriate
system so that the managing the quality in a company. The good manufacturing practices
covers all the aspects of the pharmaceutical production company so that there could be
covered the manufacturing of the products could cover all the aspects of collection of raw
materials, storage, keeping the products in the quarantine zones, labelling, keeping a
continuous checks on the quality of the drug products. The Good manufacturing practices
also aims at generating a structure for proper guidelines for maintaining and keeping the
Standard Operating Procedures, by which the company could keep a record of the drugs
which are coming and going out from the pharmaceutical companies. One of the important
part of the Good Manufacturing Practices include Quality management. In Quality
management there is an incorporating and linking of Quality Assurance or QA, Quality
Control or QC. The main purpose of the Quality management is proper handling and control
of Active Pharmaceutical Ingredient or API (International Conference of Harmonisation of
Technical Requirements for Registration OF Pharmaceuticals for Human use 2019). The
active pharmaceutical ingredient is an important part of any pharmaceutical product and any
deviation or breaching of the protocol has to be addressed and answered with proper
justification. From the good manufacturing practice, when handling the active pharmaceutical
Ingredient the proper equipment as well as the attire should be worn, to eliminate any kind of
contamination in the way of manufacturing process of any drug. Raw material selection as
well as the selection of active pharmaceutical ingredient is also an important aspect on the
basis of which the materials are accepted or rejected. The raw materials and API should be
taken from the approved vendors, and should be checked every time while preparation of the
drug. There are different parts of processing in a pharmaceutical company and some involved

REVIEW GMP
the mechanical processing of the drugs after it has been recovered or passed the test regarding
to the quality. There are different protocols when it comes to the processing of the materials
and drugs, for chemicals, plant extracts, herbal extracts and other products which are
processed through fermentation have different structure, which has to be in accordance with
guidelines. The documentation part is done by the quality assurance and the quality control
together, the batch manufacturing product are tested and recorded with batch to batch
maintaining the records. The documentation of each Standard Operating Procedure, Working
methods are recorded and has to be circulated towards the authorized person who is in charge
or the concerned person who is taking in control in that particular area. Internal audits are
another important parameters of self-inspection so that there could be less mistakes when
compounding all the data and progress updates. Furthermore, it is responsible towards the
personal maintenance of hygiene which is an essential part of the Good Manufacturing
Practice and quality assurance. Good sanitation and health habits and checking it is one of the
key parameters of Quality Management.
Part b: Any pharmaceutical plant has a part of documentation and records. The good
documentation practice is a way or method so that there is a continuous checks of records and
current implementation of any new procedure or machinery in the plant. By authorising and
assigning the documents, it keeps the check on the progress of the manufacturing unit and as
well as helps in maintaining batch records of a company (European Commission 2019). In
the section of 4.9, the any existing of new document which has been alerted has to be
circulated and signed. Good documentation Practice is an important part of quality assurance
which should be in accordance with the good manufacturing practice and in accordance with
the Good manufacturing practice requirements. In a pharmaceutical settings there are many
mediums by which documentation is done, it can be either hand written or in the electronic
media or it can be also photographic media. Any manufacturing pharmaceutical plant has a