This document outlines good practices for production operations according to manufacturing and marketing authorizations. It discusses that all handling of materials and products should follow written procedures and be recorded. Deviations from procedures should be avoided or documented. Access should be restricted and operations separated to prevent cross-contamination. Production areas and equipment must be cleaned and free of materials not required before processing. Controls and monitoring ensure proper functioning of equipment and detection of contamination.

1. Good Practices in
Production
Presented By
Md. Shariful Islam
Department of Pharmacy
International Islamic University Chittagong

2. Good Practices in Production: General
Production operations must
follow clearly defined
procedures in accordance with
manufacturing and marketing
authorizations, with the
objective of obtaining products
of the requisite quality.

3. Good Practices in Production: General
 All handling of materials and products;
 receipt
 cleaning
 quarantine
 sampling
 storage
 labeling
 dispensing
 processing
 packaging
 distribution
 should be done in accordance with written procedures and recorded.

4. Good Practices in Production: General
 Any deviation from instructions or procedures should be avoid as far as possible.
 If deviations occur: should be done in accordance with an approved procedure
 approved in writing by a designated person

5. Good Practices in Production: General
 Checks on yields and reconciliation of quantities to ensure that there are no
discrepancies outside acceptable limits.

6. Good Practices in Production: General
 Operation on different products should not be carried out simultaneously or
consecutively in the same room or area unless there is no risk of mix-up or
cross-contamination.

7. Good Practices in Production: General
 At all time during processing
 all materials
 bulk containers
 major items of equipment
 rooms
 packaging lines
 being used should be labeled or identified

8. Good Practices in Production: General
 Access to production premises should be restricted to authorized personnel.
 Non-medicinal products should not be produced in areas or with equipment
destined for the production of pharmaceutical products.

9. Good Practices in Production: General
 In-process controls are usually performed within the production area.
 The performance should not have any negative effect on the quality of the product
or another product.

10. Good practices in production: Prevention
of cross-contamination during production
 When dry materials and products are used in production, special precaution
should be taken to prevent the generation and dissemination of dust.
 proper air control e.g. supply and extraction of air of suitable quality

11. Good practices in production: Prevention
of cross-contamination during production
 Contamination of a starting material or of a product by another material
or product must be avoid.
 accidental cross-contamination arises from
 uncontrolled release of dust, gases, particles, vapours. sprays or organisms from
materials and products in process
 residues on equipment
 intruding insects
 operators’ clothing, skin, etc.
 most hazardous, highly sensitizing materials
 living organisms, hormones, cytotoxic substances, and others

12. Good practices in production: Prevention
of cross-contamination during production
 Avoided by taking appropriate technical e.g.
 carrying out production in dedicated and self-contained areas
 conducting campaign production followed by appropriate cleaning in accordance
with a validated cleaning procedure
 providing appropriately designed airlocks, pressure differentials and air supply and
extraction systems

13. Good practices in production: Prevention
of cross-contamination during production
 minimizing the risk of contamination caused by recirculation or re-entry of
untreated or insufficiently treated air
 wearing protective clothing
 using cleaning and decontamination procedures of known effectiveness
 using a closed system in production
 testing for residues
 using cleanliness status labels on equipment

14. Good practices in production: Prevention
of cross-contamination during production
 Measures to prevent cross-contamination and their effectiveness should be
checked periodically according to SOP.
 Production areas periodic
environmental monitoring

15. Good practices in production: Processing
operations
 Before any processing operation
 work area and equipment
 clean and free from any starting materials, products, product residues, labels or documents
not required for the current operation.

16. Good practices in production: Processing
operations
 Any necessary in-process controls and environmental controls should be
carried out and recorded
 Indicate the failures of equipment or services (e.g. water, gas) to equipment
 defective EQ withdrawn
 after use, production EQ
 cleaned without delay,
 stored under clean and dry conditions in separate area

17. Good practices in production: Processing
operations
 Time limits for storage of EQ after cleaning and before use
 Containers for filling should be cleaned before filling
 Any significant deviation from the expected yield
 recorded and investigated

18. Good practices in production: Processing
operations
 Checks
 pipelines and other pieces of EQ used for transportation of products
 Pipe used for conveying distilled or deionized water
 sanitized and stored according to written procedures (action limits for
microbiological contamination and measures

19. Good practices in production: Processing
operations
 EQ and instruments
 serviced and calibrated at prespecified interval
 records maintained
 checked daily or prior to use
 clearly indicated the date of calibration and servicing, recalibration (label attached
to instrument)
 Repair and maintenance operations
 not present any hazard to the quality of the products