GOOD MANUFACTURING PRACTICES

1. GOOD
MANUFACTURING
PRACTICE
NIDHI SHARMA

2. INTRODUCTION
• Good Manufacturing Practice (GMP) is a system for ensuring that products are
consistently produced and controlled according to quality standards.
• It is designed to minimize the risks involved in any pharmaceutical production that
cannot be eliminated through testing the final product.
• GMP covers all aspects of production from the starting materials, premises, and
equipment to the training and personal hygiene of staff.
• Detailed written procedures are essential for each process that could affect the quality
of the finished product.
• There must be systems to provide documented proof that correct procedures are
consistently followed at each step in the manufacturing process - every time a product
is made.

3. A BASIC OUTLINE OF GMP
• The production and distribution of the drugs must minimize any risk to their quality.
• Manufacturing facilities must maintain a clean and hygienic manufacturing area,
including laboratories and storage.
• Manufacturing facility design, operating principles and environmental conditions must
be controlled in order to prevent cross contamination of drug products, and to prevent
cross contamination from labelled or unlabelled material or products.
• Manufacturing processes must be clearly defined, validated and controlled to ensure
consistency and compliance with specifications. Any changes to the process are
evaluated from a patient safety and product quality perspective, and any approved
change that may affect the quality of the drug are qualified or validated as necessary.
• Instructions and procedures must be written in clear and unambiguous language.

4. •Operators should be trained to carry out the production and control of products according
to documented and approved procedures.
•Records should be made during manufacture and quality control, demonstrating that all
the necessary steps required by the defined procedures and instructions were executed as
defined, and that the specified quality attributes of the products have been met.
Deviations are investigated and documented.
•The process should remain in a state of control throughout the product lifecycle and
improvements done as needed.
•Records of manufacture (including distribution) are retained in a comprehensible and
accessible format that can trace the complete history of a batch.
•A system must be available for recalling any batch from sale or supply.
•Complaints about marketed products should be examined, the causes of quality defects
investigated, and appropriate measures taken with respect to the defective products and
to prevent recurrence.

5. GMP guidelines are not prescriptive instructions on how to manufacture products. They
are a series of general principles that must be applied during manufacturing. When a
company is setting up its pharmaceutical quality system, manufacturing processes and
control, there may be many ways to fulfil GMP requirements. It is the company's
responsibility to determine the most effective and efficient quality process.

6. Why is GMP so important in pharma engineering?
Poor quality drugs can be a disaster for both patients and governments from a health and
a cost perspective. If companies cannot manufacture appropriate quality products due to
GMP issues (the most common reason) there is a high risk of drug shortage, which
unfortunately affects patients who cannot get their prescribed medication when they
need it.
The pharmaceutical industry has a responsibility to ensure their safe and sufficient
supply, and this must be taken into consideration in pharma engineering and consulting
projects from the outset.
• Additionally, GMP can help boost pharmaceutical export opportunities. The majority
of countries worldwide only accept the import and sale of medicines that have been
manufactured to internationally recognised GMP standards.
• Investing in GMP means investing in quality medicine. It saves costs, minimizes risks,
and improves the standard of drugs worldwide.

7. GMP REGULATION
• Anyone who takes part in the production of medicinal products or active
pharmaceutical ingredients must comply with GMP regulations, regardless of
whether that individual is employed in
• Executive Management
• Quality Management
• Production
• Quality Control or
• Engineering
of a pharmaceutical company or supplier.

8. Every employee must know, follow and implement GMP regulations. Even small errors can
have disastrous consequences. Such incidents can lead to official sanctions ranging from
suspending sales or closing down the company, all the way to criminal prosecution of the
persons responsible. The great challenge is to be familiar with all requirements, to interpret
them correctly and to implement them in a timely fashion.
You can protect yourself with
•proper organisation
•appropriate processes
•correct documentation and
•up-to-date information.
Our publications form the benchmark for GMP information. We know what counts for you
when it comes to taking the right steps at all times. With us you will find
•a compilation of the most important laws and guidelines.
•a broad-based team of experts from government and industry.
•well-founded expert knowledge presented understandably.
•tips and pointers for putting the requirements into practice.

9. How to Sustain GMP Compliance
GMP compliance regulations are developed to enhance the safety of manufactured
products, especially pharmaceutical goods, and to ensure consumers get the highest
quality possible. GMP compliance not only positively impacts the reputation of
manufacturing companies but also reduces batch recalls and negative reports from
consumers. Below are 5 measures you can follow to sustain GMP compliance:
1.Quality team-
Have a team of skilled workers that will focus on improving current manufacturing
procedures and complying with GMP. Members will perform quality assessments on
operations to identify problems and develop appropriate corrective measures. Part of the
team’s responsibility will also be performing scheduled monitoring of instruments,
equipment, processes, and staff skills.

10. 2.Validation-
Validation is the documented act of demonstrating instruments, processes, and activities that are regularly
used or done.This is done to check if they function according to expectations.GMP can involve a number of
things to be validated, but it’s good to focus on the following processes:
1. Process validation
2.Cleaning and sanitation validation
3. Computer system validation
4.Analytical method validation
3. Surprise Audits-
A surprise audit every now and then can help gain more accurate insight on what goes on in the facility.
Identify real root causes of non-compliance and take action before it progresses into a larger issue. Read
more about best practices in doing GMP audits.
4. ComplianceTraining-
Providing compliance training to staff is the best way to ensure GMP compliance. Help staff gain a better
understanding of GMP and continually improve operations or systems in place to ensure standards are GMP-
compliant. All employees should receive training on recordkeeping, sanitation, proper equipment handling
and labeling, and SOPs to minimize errors and maintain compliance.