INDUCTION

 PREVENTION

OF CROSS CONTAMINATION8 CQA-130

02/09/08

CIPLA

1

 2.

3. 4.
02/09/08

PREVENTION OF CROSS CONTAMINATION Cross Contamination related to premises. Working premises are situated in the areas with measures to protect the manufacturing process and packing, present with minimal risk of causing contamination of material or product Premises is maintained and daily cleaned and disinfected as per SOP. Regular sanitation and upkeep of premises is done as per SOP.
CIPLA 2

PREVENTION OF CROSS CONTAMINATION Pressure differential in the working areas is maintained as per SOP. 2. All buildings are protected against entry of insects and other pests. 3. Entry of unauthorised persons are strictly prohibited in production, QC and Stores area. 4. Dedicated self contained facilities are provided for hormones and cytotoxics.
1.
02/09/08 CIPLA 3

PREVENTION OF CROSS CONTAMINATION 1. Manufacturing of non-sterile/ sterile products is carried out in clean/aseptic areas and entry of equipment-material are separate and through airlocks. 2. Weighing and sampling of starting materials actives, exceipients are done in separate cubicles / areas under reverse laminar flow.

02/09/08

CIPLA

4

PREVENTION OF CROSS CONTAMINATION
2. 3. 4.

5.

Wherever possible, closed system is adapted during manufacturing. Packing areas are designed and laid out to avoid mixups or cross-contamination. Appropriately designed airlocks, pressure differentials, air supply and extraction system are provided. Production areas where susceptible products are processed undergo periodic environmental monitoring.
02/09/08 CIPLA 5


2.

Cross Contamination related to equipment.

PREVENTION OF CROSS CONTAMINATION

Equipments are designed as product contact surface is inert and not additive or absorptive. 3. Dedicated equipment is used for product which are difficult to clean (e.g dedicated finger bags.) 4. Equipments are cleaned as per relevant SOP and wrapped with clean poly bags when they are not in use.
02/09/08 CIPLA 6

PREVENTION OF CROSS CONTAMINATION  Cross Contamination related to equipments. (continue) 2. Vacuum cleaners are fitted with dust retaining filters. Dedicated vacuum cleaners are provided for the areas 3. Common equipment used for different products should be cleaned as per validated cleaning procedure to prevent cross contamination.
02/09/08 CIPLA 7

PREVENTION OF CROSS CONTAMINATION Cross Contamination related to equipments. 8. Dedicated trolleys are provided in each department.

02/09/08

CIPLA

8

PREVENTION OF CROSS CONTAMINATION
 2.

3. 4.

Cross Contamination related to processing operations: Care should be taken before starting of any operation in the processing area for absence of any starting material, products, product residues, previous product. Line clearance as per respective SOP. Processing of only one product should be carried out at a time in cubicle. Packing operations in packing hall should be carried out using physical segregation between packing lines.
CIPLA 9

02/09/08

PREVENTION OF CROSS CONTAMINATION 1. At all stages of processing product or material particularly primary packing material are protected from microbial and other contamination. 2. Common containers, IPC’s and bins are thoroughly cleaned before every use to avoid any possible cross contamination. 3. Outer wrapping of packaging material is removed before the material is issued on the shop floor.
02/09/08 CIPLA 10

1.

2. 3.

4.

Containers for filling should be cleaned before use to avoid and remove any contamination due to glass fragments and metal particles. Product and product contact parts are not handled directly with bare hands. Campaign production should be followed by appropriate cleaning in accordance with validated cleaning procedure. Materials such as lubricants, inks, cleaning fluids should be kept in distinctly different looking containers from containers used in production and should be labeled as per content.
CIPLA 11

PREVENTION OF CROSS CONTAMINATION

02/09/08

PREVENTION OF CROSS CONTAMINATION Cross Contamination related to Clothing: 2. Clothing and quality should be appropriate for the process and grade of working area. 3. Clothing should be worn in such a way that it protects the product and person from contamination. 4. Clothing should be routinely washed at appropriate laundry facility.

02/09/08 CIPLA 12

PREVENTION OF CROSS CONTAMINATION During washing of linen/ clothes it is ensured that they are not contaminated with cleaning agent. 2. Appropriate PPE should be used when product with special risk are handled. 3. Clothing / linen should be changed after every product change over.
1.

02/09/08

CIPLA

13