This document discusses Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs). It defines GMP as ensuring quality standards in drug production and outlines its main principles, including organization, facilities, equipment, materials control, production processes, packaging, and records. SOPs are defined as written instructions for routine tasks and the document discusses benefits like consistent performance, quality assurance, and training. A typical SOP structure is also outlined.

1. GOOD MANUFACTURING
PRACTICES & STANDARD
OPERATING PROCEDURE

2. GOOD MANUFACTURING PRACTICES &
STANDARD OPERATING PROCEDURE?
• GOOD MANUFACTURING PRACTICES & STANDARD OPERATING
PROCEDURE: -
• WHAT IS GOOD MANUFACTURING PRACTICE?
• THE BENEFITS OF GMPs.
• MAIN PRINCIPLES OF GMP
• WHAT IS AN S.O.P?
• BENEFITS OF SOP FEATURES OF A “GOOD” STANDARD
OPERATING PROCEDURE.
• TYPICAL STRUCTURE FOR SOPs.

3. WHY / NEED OF GMP?
• STAY UPDATED FOR GOOD
• CHANGE FORE GOOD
• EARROR PREVENTION
• ERROR DETEVTION

4. WHAT IS GOOD MANUFACTURING PRACTICE?
Good Manufacturing Practices (GMP) are the part of quality assurance
that ensures that drugs are consistently produced and controlled in such
a way to meet the quality standards appropriate to their intended use, as
required by the marketing authorization. Based on fundamental
concepts of Quality Assurance Principles Control Quality, safety, and
effectiveness must be designed and built into the product Quality
cannot be inspected or tested into a finished product Each step of
manufacturing must be controlled to maximize the chances that the
Finished Good will be acceptable.

5. WHAT ARE THE BENEFITS OF GMPS?
They outline a Quality System that reduces or prevents errors
1. Ensures products are safe for use in humans
2. Prevent/control contamination and cross-contamination
3. Minimizes variations in potency of the drug
4. Ensures reproducible physiological activity
5. Prevent side effects and toxicity due to variations in drug content
and potency
6. Prevents mislabelling and adulteration

6. MAIN KEY PRINCIPLES OF GMP
1. Organization and Personnel
2. Buildings and Facilities
3. Equipment
4. Control of Components and Product Containers and Closures
5. Production and Process Controls
6. Packaging & Labelling Control
7. Holding & Distribution

7. MAIN KEY PRINCIPLES OF GMP (contd….)
8. Laboratory Controls › Records & Reports › Returned & Salvaged
Drug Product
9. Conducts planed and periodic audits
10. Available written approved instruction or procedure before any
job is started.
11. Outsource activities
12. Complaints and product recall
13. Self inspection

8. Organization and Personnel
Management Responsibility: -
 Responsible for facility, quality system, organizational structure,
ensuring adequate resources.
 Responsible for actions of those reporting to them.
 Responsible for reviewing products annually, and procedures
routinely.
 Responsible for providing adequate resources to perform
operations Facilities, personnel, training, equipment, etc.
 There shall be an adequate number of qualified personnel to
perform the job.
MAIN KEY PRINCIPLES OF GMP (contd….)

9. Organization and Personnel
Personal Responsible: -
 To wear clean clothing and protective apparel appropriate for the
duties they perform.
 To practice good sensitisation and health's habits.
 Sickness and recertification of fitness before joining the
organization after specific days ( E.g. after two days)
MAIN KEY PRINCIPLES OF GMP (contd….)

10. Buildings and Facilities
 Buildings must be designed with adequate size and space for
operations
 Facilities must be validated
 There must be a good flow pattern for personnel, materials, products
and waste materials.
 The facility must be easy to clean and sanitize
 Environmental controls must be in place
 Utilities must be validated (water systems, electrical, etc)
MAIN KEY PRINCIPLES OF GMP (contd….)

11. Buildings and Facilities
 Drains of adequate sites
 Disposal of wastage in set manner
 Adequate washing and toilet facilities
 Maintenance of building in a good sate of repair.
 Equipment should be selected based on the intended use and clean
ability if it is to be in a clean room Equipment must be placed in an
appropriate location.
 Equipment must be properly qualified.
MAIN KEY PRINCIPLES OF GMP (contd….)

12. Control of Components and Product Containers and Closures
 Component/Materials Control Suppliers must be evaluated and
approved and monitored for quality Incoming Materials must be tested
before they can be accepted for use Materials must be placed in stores
or issued according to FIFO (stock rotation) Materials must be stored so
that they are not mixed up, damaged, or contaminated.
 Production/Process Control Have & Follow Procedures: A good
procedure is a written step-by-step procedure that provides a roadmap
for Controlled and Consistent performance.
 Examples: 1. (Manufacturing) Work Instructions
2. Operating Procedures
3. Testing Procedures
4. Quality Manual Deviations must be recorded and justified
MAIN KEY PRINCIPLES OF GMP (contd….)

13. Packaging & Labelling Control
Packaging and Labelling Control Label is a display of a written, printed or
graphic matter upon the immediate container of any article Labelling is the
label and any other packaging material or container that is printed (ex. IFU,
advertising materials) Procedures must exist that document receiving,
identity, storage, handling, sampling, and testing of labels and ensure that
integrity is maintained throughout production and use of product
 Holding and Distribution Warehousing procedures should address…
 Quarantine of drug products …
 Storage of products under appropriate conditions Distribution
procedures should address… …
 FEFO (First Expiring First Out) …
 Traceability of product lots/batches: - Laboratory Controls Written
procedures must be established & followed All actions must be
documented at the time of performance.
MAIN KEY PRINCIPLES OF GMP (contd….)

14. Records & Reports
Records and Reports Quality Records are the proof that the procedures
were followed and they show traceability of product.
Quality Records
 Records are legal documents and can be subpoenaed in a court of law
as evidence.
 Signatures on documentation have the same meaning as on any kind
of contract.
 Information must be recorded and signed for at the time of
performance on the original record.
MAIN KEY PRINCIPLES OF GMP (contd….)

15. WHAT IS AN SOP?

16. Standard Operating Procedure (SOP) is a set of
written instructions that document a routine or
repetitive activity followed by an organization

17. Should provide all the information necessary to perform a task.
Is usually specific to the equipment used for the procedure.
Should be detailed.
Should “Stand Alone”.
Should provide Quality Control information.
Should provide References.
FEATURES OF A “GOOD” STANDARD
OPERATING PROCEDURE

18.  To perform a job properly.
 To ensure that production operations are performed consistently.
 To ensure that processes continue uninterrupted and are completed on
a prescribed schedule.
 To ensure that no failures occur in manufacturing and other processes
for which the SOP was written.
 To ensure that approved procedures are followed in compliance with
company and government regulations. Quality Assurance, Quality
Square Industry.
BENEFITS OF SOP

19.  To serve as a training document for teaching users about the process.
 To serve as a checklist for co-workers who observe job performance to
reinforce proper performance.
 To serve as a checklist for auditors.
 To serve as an historical record for the Change over.
 To serve as an explanation in review of accident investigations.
BENEFITS OF SOP (Contd….)

20.  Title Page: This includes.
 the title of the procedure, an SOP identification number
 date of issue or revision,
 the name of the agency/division/branch the SOP applies to, and the
signatures of those who prepared and approved of the SOP.
 This can be formatted however you like, as long as the information is
clear.
TYPICAL STRUCTURE FOR SOPS

21. This is only necessary if SOP is quite long, allowing for ease of reference.
A simple standard outline is what you'd find here.
Quality Assurance/Quality Control:
 A procedure is not a good procedure if it cannot be checked.
 Have the necessary materials and details provided so the reader can
make sure they've obtained the desired results.
 This may or may not include other documents, like performance
evaluation samples.
TYPICAL STRUCTURE FOR SOPS

22. Reference:
Be sure to list all cited or significant references. If reference other SOPs,
its important to attach the necessary information in the appendix.
TYPICAL STRUCTURE FOR SOPs (Contd….)