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GMP Golden Rules
GMP Golden Rules
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Abstract
The basic rules in any good manufacturing practice (GMP) regulations postulate that the
pharmaceutical manufacturer must maintain appropriate documentation and records.
Documentation helps to build up a detailed interpretation of what a manufacturing function
has done in the past and what it is doing now and, thus, it provides a base for planning what
it is going to do in the future. Regulatory evaluators, during their inspections of
manufacturing sites, often devote much time on examining a company’s documents and
records. Effective documentation boosts the visibility of the quality assurance system.
3. Operating Procedures: These give There are two main reasons for this:
direction for performing certain tasks 1. Many shortcuts may create pitfalls that
and provide higher-level instruction can be costly in the end.
than operating instructions. 2. Each step in a procedure has been
4. Records: These provide a history of included for a purpose.
each batch and provide a mechanism to
check that you are following operating Even though the sense of a particular step
procedures and instructions. may not be directly apparent, it may be
there as a check for another stage of the
Writing Good Procedures process. Ideas for improvement should
Plan the task before you begin writing the always be encouraged but don’t change
procedure. Generate a brief breakdown of procedures without assessing the impact
the important steps and key points related on the entire process.
to the task; a flow chart is a useful tool.
Remember that people don’t usually read Identify Who Does What
processes from start to end; they have a All employees should clearly understand
habit of to scan the document for key what they have to do each day. It avoids
words. It’s better to break the procedure misunderstandings and minimises the risk
into portions and use like; Headings, to product quality. [8]
tables, bullet points and diagrams. This There must be a job description for each
will help to understand and follow the role to define:
procedure easily. When writing procedures 1. job title
try to visualise the person who going to 2. job objective
use these. Write in language they will 3. duties and responsibilities
understand and don’t include too much or 4. Skill requirements.
too little information. You can increase the
readability of your procedures by using There should be no gaps or overlaps in
simple sentences and by writing in a responsibilities. Create an organisational
conversational style. It is a GMP chart and display it on the intranet or a
requirement to frequently review local notice board. This way everyone in
documentation to ensure that it’s up to the organisation can see who does what.
date. Most companies have a three-year Some areas that are vulnerable to overlap
review cycle for their documents however include: cleaning, validation and
this can be set according to the possibility calibration. When preparing procedures for
of change in the procedure that the these areas carefully consider and define
document relates to. the responsibilities. It’s also vital that
employees are trained to undertake a task
Following Procedures that they are assigned responsibility too.
It’s all very well to have great written
processes in place but to certify a Keep Good Records
controlled and consistent performance they Good records empower you to track all
need to be followed; it’s a GMP requisite. activities those are performed during the
Frequently, the steps described in a written manufacturing of batch from the receiving
procedure may not appear to be the most of raw materials, to the final product
efficient way of working. Taking shortcuts release; they provide a history of the batch
may save time or make the task easier, but and its supply. [9] It is a vital part of GMP
you should never diverge from a written to keep truthful records because this will
procedure without the approval of a help during an audit; it also helps to
manager or the Quality Division [7]. convey that you are following the written
procedures. It also reveals that procedures the theory and practice of GMP as well as
are known and under control. specific training related to their job profile.
Sometimes it’s unavoidable to take an
GOOD RECORD KEEPING unexperienced visitor into a production
Follow the below mentioned guidelines area. If this happens, then it is our
to ensure that good record keeping is responsibility to provide them with some
part of your everyday culture: information in advance, mainly relating to
Record all needed information instantly personal hygiene, and closely supervise
upon accomplishment of a task. Never them at all times. It is also essential to
trust your memory or write results on loose confirm that training requirements are
pieces of paper. Write your name with highlighted as part of the change control
legibly ink. Remember that by signing system. Employees must know how to use
records you are verifying that the record is newly installed piece of equipment. It is
accurate and that you have done the task as important to check that training is
per the well-defined procedure. Its complete during validation or add it as a
necessary to draw a single line through any separate change control task. The same
mistakes, and initial and date the process will also apply for any update to
correction. Include a reason for the procedures or instructions.
correction at the bottom of the page.
Demonstrating Job Competence
Retention Requirements Employees must demonstrate their job
You must keep records for every phase of ability every day by manufacturing quality
the manufacturing process. Some required products in a safe and well-organized
records include: manner. Good manufacturing Companies
a. Product master records need people who know how to do the job
b. Batch manufacturing records right the first time, every time. Annual
c. Batch Packing records performance reviews (APR) are also a
d. Material / component control records prodigious technique to formally discuss
e. Employees records an employee’s development and
f. Training records performance. It is a good way to review,
g. Equipment log books what the employee has accomplished and
h. Cleaning log books to identify any gaps or areas for further
If you follow these guidelines, you will progress.
easily be able to examine each step of
the manufacturing process should you Practice Good Hygiene
need to [9]. Personnel hygiene plays a vital role in any
manufacturing company. It is not just
Train and Develop Staff putting sanitization program, so with that
To meet GMP necessities it’s essential to you can reduce contamination. Develop a
have the right people to do the precise job. program to meet the standards of
It is very important that employees have cleanliness necessary for the product. The
the abilities and awareness to complete fight against contamination is a constant
their job [10]. battle and is one that requires the attention
of every single employee, every day [11].
Training
It is our responsibility to provide training Keep these practices in mind:
for all employees, whose duties take them a. Always practice good personal hygiene
into production areas or laboratories, and by washing your hands and wearing
whose activities can affect the quality of the required protective garments.
the product. This includes basic training on